Type 2 DiabetesNCT00795691
Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes
A study testing low-carbohydrate diet and low-fat diet in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- low-carbohydrate diet and low-fat diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
- HbA1c 7-10%
- BMI (kg/m2) > 25 and < 40 and weight < 280 lb.
- Skill at and willingness to perform capillary blood glucose self-monitoring ---Insulin (changed to long-acting basal during run-in) or sulfonylurea treatment
Who cannot join
- Age > 65
- Weight >280 lb
- Health conditions that may interfere with study participation or for which the study interventions may be contraindicated. These include: kidney stones or kidney disease (creatinine > 1.3 and 1.5 mg/dL for females and males, respectively; proteinuria > 300 ug/g creatinine); liver or gall bladder disease; significant heart disease (myocardial infarction in the past six months, prior or current evidence of congestive heart failure, other evidence of left ventricular (LV) dysfunction) or other indices of active cardiac abnormalities, (angina, electrocardiogram evidence of ischemia or transmural myocardial infarction), significant anemia; and cancer (other than effectively treated non melanomatous skin cancer and surgically treated cervical cancer in situ).
- Current hypokalemia defined as serum potassium levels <3.5 mg/dL.
- Osteoporosis
- Type 1 diabetes (history of ketoacidosis or undetectable fasting C-peptide levels)
Show all 13Show fewer
- History of severe or repeated hypoglycemia, or hypoglycemia unawareness. Lack of recourse to another person in the immediate vicinity in the unlikely event that they require outside assistance for severe hypoglycemia.
- Triglyceride levels > 400 mg/dL.
- Inability or unwillingness to comply with any aspects of the dietary and research protocol.
- Weight changes > 10 lbs in the past three months.
- History of binge eating disorder or other eating disorders.
- Pregnancy or intention to become pregnant in the next 12 months.
- Current oral hypoglycemic medication that raises the blood insulin level
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine, General Clinical Research Center
The Bronx, New York, 10461
About this study
Official title: High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))
The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.
Read the detailed description
Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the need for insulin requirement in people with type 2 diabetes who are overweight or obese. However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases circulating insulin levels often results in additional weight gain. Controlled-carbohydrate "ketogenic" diets have been popular as an alternative way of losing weight, but little is known about the safety and efficacy of using a ketogenic approach in the management of overweight/obese patients with type 2 diabetes.
The proposed study will randomize a group of 126 overweight or obese (BMI > 25 and < 40) adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The primary study endpoint will be six and twelve month changes in glycemic control as measured by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and fat distribution); blood glucose patterns (from self-monitoring records); change in antidiabetic medications (potential decrease in number and dosage), lipids, insulin sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin) and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality of life, mood, and well-being.
- Conditions
- Type 2 Diabetes
- Being tested
- low-carbohydrate diet, low-fat diet
- Keywords
- diabetes, low-carbohydrate diet, weight loss, obesity, dietary intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-carbohydrate dietBehavioural
ketogenic low-carbohydrate diet in patients with type 2 diabetes
low-fat dietBehavioural
low-fat diet in patients with type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate diet | Experimental | The low-carbohydrate diet was based on the Atkins weight loss diet. The daily intake goals were to restrict intake of carbohydrate to 20-25 grams for the first 2-week phase. If body weight decreased, the daily goal for carbohydrate was increased by 5 grams. If body weight increased, the daily goal for carbohydrate intake was decreased by 5 grams. The minimum goal for carbohydrate intake was 20 grams per day and the maximum goal was 50 grams per day. Receives: Behavioral: low-carbohydrate diet |
| Low-fat diet | Active comparator | The low-fat diet was based on the algorithm used to restrict fat and calorie intake in the Diabetes Prevention Program. The daily goals for fat intake was based on an algorithm to reduce total calorie intake to achieve a one pound weight loss per week with 25% of calories from fat. Receives: Behavioral: low-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c at month 3
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Measured: 3 months into treatment
Hemoglobin A1c at month 6
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Measured: 6 months into treatment
Hemoglobin A1c at month 12
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Measured: 12 months into treatment
Change in Body Weight at month 3
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Measured: Baseline and 3 months into treatment
Change in Body Weight at month 6
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Measured: Baseline and 6 months into treatment
Change in Body Weight at month 12
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Measured: Baseline and 12 months into treatment
Secondary outcomes (28)
Change in Body Fat at month 6
A bioelectrical impedance analysis scale is used to measure body fat. Having a higher proportion of body fat is associated with poorer blood glucose control.
Measured: Baseline and 6 months into treatment
Change in Body Fat at month 12
A bioelectrical impedance analysis scale is used to measure body fat. Having a higher proportion of body fat is associated with poorer blood glucose control.
Measured: Baseline and 12 months into treatment
Change in Lean Body Mass at month 6
A bioelectrical impedance analysis scale is used to measure lean body mass. Having a higher proportion of lean body mass is associated with better blood sugar control.
Measured: Baseline and 6 months into treatment
Change in Lean Body Mass at month 12
A bioelectrical impedance analysis scale is used to measure lean body mass. A higher proportion of lean mass is associated with better blood sugar control.
Measured: Baseline and 12 months into treatment
Change in antidiabetic medication dosage at month 3
If medication dosage is reduced, it generally indicates that blood glucose is better controlled. If dosage increases, it generally indicates that blood glucose was not well controlled.
Measured: Baseline and 3 months into treatment
Change in antidiabetic medication dosage at month 6
If medication dosage is reduced, it generally indicates that blood glucose is better controlled. If dosage increases, it generally indicates that blood glucose was not well controlled.
Measured: Baseline and 6 months into treatment
Change in antidiabetic medication dosage at month 12
If medication dosage is reduced, it generally indicates that blood glucose is better controlled. If dosage increases, it generally indicates that blood glucose was not well controlled.
Measured: Baseline and 12 months into treatment
Change in insulin sensitivity at month 6
Insulin sensitivity is calculated from the fasting blood glucose and insulin levels derived from laboratory tests. An increase in insulin sensitivity relates to better blood glucose control. A reduction in insulin sensitivity is related to poorer blood glucose control.
Measured: Baseline and 6 months into treatment
Total Cholesterol at month 6
Blood level of total cholesterol measures cardiovascular risk. Total cholesterol is reduced with weight loss. The change would be an indication of reduction in cardiovascular risk.
Measured: 6 months into treatment
Total Cholesterol at month 12
Blood level of total cholesterol measures cardiovascular risk. Total cholesterol is reduced with weight loss. The change would be an indication of reduction in cardiovascular risk.
Measured: 12 months into treatment
High-density lipoprotein cholesterol at month 6
Blood level of high density lipoprotein (HDL) cholesterol, measures cardiovascular risk. HDL cholesterol is expected to increase with weight loss. The change would be an indication of reduction in cardiovascular risk.
Measured: 6 months into treatment
High-density lipoprotein cholesterol at month 12
Blood level of high density lipoprotein (HDL) cholesterol, measures cardiovascular risk. HDL cholesterol is expected to increase with weight loss. The change would be an indication of reduction in cardiovascular risk.
Measured: 12 months into treatment
Low-density lipoprotein cholesterol at month 6
Low density lipoproteins (LDL) cholesterol measures cardiovascular risk. LDL cholesterol is expected to be reduced with weight loss. This change would be an indication of reduction in cardiovascular risk.
Measured: 6 months into treatment
Low-density lipoprotein cholesterol at month 12
Low density lipoprotein (LDL) cholesterol measures cardiovascular risk. LDL cholesterol is expected to be reduced with weight loss. This change would be an indication of reduction in cardiovascular risk.
Measured: 12 months into treatment
Triglycerides at month 6
Blood Triglyceride levels measure cardiovascular risk. Triglycerides are expected to be reduced with weight loss. This change would be an indication of reduction in cardiovascular risk.
Measured: 6 months into treatment
Triglycerides cholesterol at month 12
The blood level of triglycerides measures cardiovascular risk. Triglycerides are expected to be reduced with weight loss. This change would be an indication of reduction in cardiovascular risk.
Measured: 12 months into treatment
Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Dietary intake is assessed using the Dietary History Questionnaire (DHQ), a web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total energy (calories) consumed are based on the nutrient values from NHANES. It is anticipated that a decrease in calorie intake would result in body weight reduction which normally correlates to increased blood glucose control. Likewise, an increase in calories generally result in body weight increase which correlates to decreased blood glucose control.
Measured: 6 months into treatment
Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Dietary intake is assessed using the Dietary History Questionnaire (DHQ), a web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total energy (calories) consumed are based on the nutrient values from NHANES. It is anticipated that a decrease in calorie intake would result in body weight reduction which normally correlates to increased blood glucose control. Likewise, an increase in calories generally result in body weight increase which correlates to decreased blood glucose control.
Measured: 12 months into treatment
Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Dietary carbohydrate intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of carbohydrates are based on the nutrient values from NHANES. It is anticipated that an increase in carbohydrate intake would result in an increase in blood HbA1c level, and a decrease in carbohydrate intake would result in a decrease in the blood HbA1c level.
Measured: 6 months into treatment
Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Dietary carbohydrate intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of carbohydrates are based on the nutrient values from NHANES. It is anticipated that an increase in carbohydrate intake would result in an increase in blood HbA1c level, and a decrease in carbohydrate intake would result in a decrease in the blood HbA1c level.
Measured: 12 months into treatment
Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Dietary fat intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of fat (saturated fat, monounsaturated fat and polyunsaturated fat) are based on the nutrient values from NHANES. It is anticipated that an increase in fat intake would result in an increase in total and LDL blood cholesterol levels, and a decrease in fat intake would result in a decrease in total and LDL blood cholesterol levels.
Measured: 6 months into treatment
Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Dietary fat intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of fat (saturated fat, monounsaturated fat and polyunsaturated fat) are based on the nutrient values from NHANES. It is anticipated that an increase in fat intake would result in an increase in total and LDL blood cholesterol levels, and a decrease in fat intake would result in a decrease in total and LDL blood cholesterol levels.
Measured: 12 months into treatment
Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Dietary protein intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of protein are based on the nutrient values from NHANES. It is anticipated that an increase in protein intake (relative to carbohydrate) will result in loss of body fat and reduction in body weight, while a decrease in protein intake(relative to carbohydrate) will result in increased body fat and body weight.
Measured: 6 months into treatment
Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Dietary protein intake is assessed using the Dietary History Questionnaire (DHQ), which is web-based food frequency questionnaire. Participants select the serving size and frequency of intake for the foods listed. The items listed and serving size choices are derived from the National Health and Nutrition Examination Survey (NHANES). Calculations of total intake (in grams) of protein are based on the nutrient values from NHANES. It is anticipated that an increase in protein intake (relative to carbohydrate) will result in loss of body fat and reduction in body weight, while a decrease in protein intake(relative to carbohydrate) will result in increased body fat and body weight.
Measured: 12 months into treatment
Physical activity was assessed by patient self-report at month 6
Physical activity was assessed using the Modifiable Physical activity Questionnaire (MAQ) with the 7-Day Physical Activity Recall interview. Participants were asked to provide information about the frequency, duration and intensity of various physical activities. MAQ responses and 7-day recall data were coded and entered into software program, which was designed to calculate average daily energy expenditure. Participants were instructed to avoid changing physical activity while in the study because change in physical activity could confound assessment of the dietary questions. An increase in physical activity could increase loss of body weight and reduction in blood HbA1c. A decrease in physical activity could increase body weight and increase HbA1c.
Measured: 6 months into treatment
Physical activity was assessed by patient self-report at month 12
Physical activity was assessed using the Modifiable Physical activity Questionnaire (MAQ) with the 7-Day Physical Activity Recall interview. Participants were asked to provide information about the frequency, duration and intensity of various physical activities. MAQ responses and 7-day recall data were coded and entered into software program, which was designed to calculate average daily energy expenditure. Participants were instructed to avoid changing physical activity while in the study because change in physical activity could confound assessment of the dietary questions. An increase in physical activity could increase loss of body weight and reduction in blood HbA1c. A decrease in physical activity could increase body weight and increase HbA1c.
Measured: 12 months into treatment
Quality of life as assessed using the Diabetes Quality of Life Scale at month 6
Quality of Life is assessed using the Diabetes Quality of Life (DQOL) questionnaire. The DQOL questionnaire contains 62 items which participants rank from 1(very satisfied) to 5 (very dissatisfied). The score gives an indication of participants' satisfaction with treatment in terms of level of well-being and disability. The total score ranges from 0 to 310. The score is negatively correlated to Quality of Life with higher scores indicating higher dissatisfaction and therefore, lower perceived Quality of Life. It is expected that reduction in the blood HbA1c level will be associated with an increase in the Diabetes Quality of Life (i.e. a decrease in DQOL score), and an increase in the HbA1c level will correlate to a lower Diabetes Quality of Life (i.e. an increase in DQOL score).
Measured: 6 months into treatment
Quality of life as assessed using the Diabetes Quality of Life Scale at month 12
Quality of Life is assessed using the Diabetes Quality of Life (DQOL) questionnaire. The DQOL questionnaire contains 62 items which participants rank from 1(very satisfied) to 5 (very dissatisfied). The score gives an indication of participants' satisfaction with treatment in terms of level of well-being and disability. The total score ranges from 0 to 310. The score is negatively correlated to Quality of Life with higher scores indicating higher dissatisfaction and therefore, lower perceived Quality of Life. It is expected that reduction in the blood HbA1c level will be associated with an increase in the Diabetes Quality of Life (i.e. a decrease in DQOL score), and an increase in the HbA1c level will correlate to a lower Diabetes Quality of Life (i.e. an increase in DQOL score).
Measured: 12 months into treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startMay 2004
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Responsible party
- Principal investigator, Judith Wylie-Rosett, Albert Einstein College of Medicine
- Investigators
- Judith Wylie-Rosett, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795691
- Sponsor's protocol ID
- 2002-180
- Status last verified
- Jul 2019
- First submitted
- 20 Nov 2008
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cunningham C, Johnson S, Cowell B, Soroudi N, Segal-Isaacson CJ, Davis NJ, Isasi CR, Wylie-Rosett J. Menu plans in a diabetes self-management weight loss program. J Nutr Educ Behav. 2006 Jul-Aug;38(4):264-6. doi: 10.1016/j.jneb.2006.01.013. No abstract available.
PubMed 16785099Davis NJ, Cohen HW, Wylie-Rosett J, Stein D. Serum potassium changes with initiating low-carbohydrate compared to a low-fat weight loss diet in type 2 diabetes. South Med J. 2008 Jan;101(1):46-9. doi: 10.1097/SMJ.0b013e31815d2696.
PubMed 18176291Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, Zonszein J, Wylie-Rosett J. Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1147-52. doi: 10.2337/dc08-2108. Epub 2009 Apr 14.
PubMed 19366978Davis NJ, Tomuta N, Isasi CR, Leung V, Wylie-Rosett J. Diabetes-specific quality of life after a low-carbohydrate and low-fat dietary intervention. Diabetes Educ. 2012 Mar-Apr;38(2):250-5. doi: 10.1177/0145721711436132. Epub 2012 Feb 7.
PubMed 22316641Davis NJ, Crandall JP, Gajavelli S, Berman JW, Tomuta N, Wylie-Rosett J, Katz SD. Differential effects of low-carbohydrate and low-fat diets on inflammation and endothelial function in diabetes. J Diabetes Complications. 2011 Nov-Dec;25(6):371-6. doi: 10.1016/j.jdiacomp.2011.08.001. Epub 2011 Oct 27.
PubMed 22036100
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))
- ClinicalTrials.gov ID
- NCT00795691
- Acronym / sponsor ID
- 2002-180
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes, low-carbohydrate diet, weight loss, obesity, dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Robert C. Atkins Foundation
- Study start
- May 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.
Detailed description
Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the need for insulin requirement in people with type 2 diabetes who are overweight or obese. However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases circulating insulin levels often results in additional weight gain. Controlled-carbohydrate "ketogenic" diets have been popular as an alternative way of losing weight, but little is known about the safety and efficacy of using a ketogenic approach in the management of overweight/obese patients with type 2 diabetes.
The proposed study will randomize a group of 126 overweight or obese (BMI > 25 and < 40) adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The primary study endpoint will be six and twelve month changes in glycemic control as measured by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and fat distribution); blood glucose patterns (from self-monitoring records); change in antidiabetic medications (potential decrease in number and dosage), lipids, insulin sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin) and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality of life, mood, and well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate diet | Experimental | Behavioral: low-carbohydrate dietThe low-carbohydrate diet was based on the Atkins weight loss diet. The daily intake goals were to restrict intake of carbohydrate to 20-25 grams for the first 2-week phase. If body weight decreased, the daily goal for carbohydrate was increased by 5 grams. If body weight increased, the daily goal for carbohydrate intake was decreased by 5 grams. The minimum goal for carbohydrate intake was 20 grams per day and the maximum goal was 50 grams per day. |
| Low-fat diet | Active comparator | Behavioral: low-fat dietThe low-fat diet was based on the algorithm used to restrict fat and calorie intake in the Diabetes Prevention Program. The daily goals for fat intake was based on an algorithm to reduce total calorie intake to achieve a one pound weight loss per week with 25% of calories from fat. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes
- HbA1c 7-10%
- BMI (kg/m2) > 25 and < 40 and weight < 280 lb.
- Skill at and willingness to perform capillary blood glucose self-monitoring ---Insulin (changed to long-acting basal during run-in) or sulfonylurea treatment
Key exclusion criteria (13 listed)
- Age > 65
- Weight >280 lb
- Health conditions that may interfere with study participation or for which the study interventions may be contraindicated. These include: kidney stones or kidney disease (creatinine > 1.3 and 1.5 mg/dL for females and males, respectively; proteinuria > 300 ug/g creatinine); liver or gall bladder disease; significant heart disease (myocardial infarction in the past six months, prior or current evidence of congestive heart failure, other evidence of left ventricular (LV) dysfunction) or other indices of active cardiac abnormalities, (angina, electrocardiogram evidence of ischemia or transmural myocardial infarction), significant anemia; and cancer (other than effectively treated non melanomatous skin cancer and surgically treated cervical cancer in situ).
- Current hypokalemia defined as serum potassium levels <3.5 mg/dL.
- Osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-carbohydrate dietketogenic low-carbohydrate diet in patients with type 2 diabetes | Behavioural | Low-carbohydrate diet |
| low-fat dietlow-fat diet in patients with type 2 diabetes | Behavioural | Low-fat diet |
Primary outcome
Hemoglobin A1c at month 3
Time frame: 3 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Hemoglobin A1c at month 6
Time frame: 6 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Hemoglobin A1c at month 12
Time frame: 12 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Change in Body Weight at month 3
Time frame: Baseline and 3 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Change in Body Weight at month 6
Time frame: Baseline and 6 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Change in Body Weight at month 12
Time frame: Baseline and 12 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
28 secondary outcomes
Change in Body Fat at month 6
Time frame: Baseline and 6 months into treatment
Change in Body Fat at month 12
Time frame: Baseline and 12 months into treatment
Change in Lean Body Mass at month 6
Time frame: Baseline and 6 months into treatment
Change in Lean Body Mass at month 12
Time frame: Baseline and 12 months into treatment
Change in antidiabetic medication dosage at month 3
Time frame: Baseline and 3 months into treatment
Change in antidiabetic medication dosage at month 6
Time frame: Baseline and 6 months into treatment
Change in antidiabetic medication dosage at month 12
Time frame: Baseline and 12 months into treatment
Change in insulin sensitivity at month 6
Time frame: Baseline and 6 months into treatment
Total Cholesterol at month 6
Time frame: 6 months into treatment
Total Cholesterol at month 12
Time frame: 12 months into treatment
High-density lipoprotein cholesterol at month 6
Time frame: 6 months into treatment
High-density lipoprotein cholesterol at month 12
Time frame: 12 months into treatment
Low-density lipoprotein cholesterol at month 6
Time frame: 6 months into treatment
Low-density lipoprotein cholesterol at month 12
Time frame: 12 months into treatment
Triglycerides at month 6
Time frame: 6 months into treatment
Triglycerides cholesterol at month 12
Time frame: 12 months into treatment
Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Time frame: 6 months into treatment
Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Time frame: 12 months into treatment
Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Time frame: 6 months into treatment
Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Time frame: 12 months into treatment
Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Time frame: 6 months into treatment
Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Time frame: 12 months into treatment
Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
Time frame: 6 months into treatment
Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
Time frame: 12 months into treatment
Physical activity was assessed by patient self-report at month 6
Time frame: 6 months into treatment
Physical activity was assessed by patient self-report at month 12
Time frame: 12 months into treatment
Quality of life as assessed using the Diabetes Quality of Life Scale at month 6
Time frame: 6 months into treatment
Quality of life as assessed using the Diabetes Quality of Life Scale at month 12
Time frame: 12 months into treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Background: PubMed 16785099Cunningham C, Johnson S, Cowell B, Soroudi N, Segal-Isaacson CJ, Davis NJ, Isasi CR, Wylie-Rosett J. Menu plans in a diabetes self-management weight loss program. J Nutr Educ Behav. 2006 Jul-Aug;38(4):264-6. doi: 10.1016/j.jneb.2006.01.013. No abstract available.
- Background: PubMed 18176291Davis NJ, Cohen HW, Wylie-Rosett J, Stein D. Serum potassium changes with initiating low-carbohydrate compared to a low-fat weight loss diet in type 2 diabetes. South Med J. 2008 Jan;101(1):46-9. doi: 10.1097/SMJ.0b013e31815d2696.
- Results publication: PubMed 19366978Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, Zonszein J, Wylie-Rosett J. Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1147-52. doi: 10.2337/dc08-2108. Epub 2009 Apr 14.
- Derived from this study: PubMed 22316641Davis NJ, Tomuta N, Isasi CR, Leung V, Wylie-Rosett J. Diabetes-specific quality of life after a low-carbohydrate and low-fat dietary intervention. Diabetes Educ. 2012 Mar-Apr;38(2):250-5. doi: 10.1177/0145721711436132. Epub 2012 Feb 7.
- Derived from this study: PubMed 22036100Davis NJ, Crandall JP, Gajavelli S, Berman JW, Tomuta N, Wylie-Rosett J, Katz SD. Differential effects of low-carbohydrate and low-fat diets on inflammation and endothelial function in diabetes. J Diabetes Complications. 2011 Nov-Dec;25(6):371-6. doi: 10.1016/j.jdiacomp.2011.08.001. Epub 2011 Oct 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Wylie-Rosett principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-carbohydrate diet and low-fat diet in people with Type 2 Diabetes, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c at month 3 (time frame: 3 months into treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795691, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.