Diabetes Mellitus, Type 1T1DLoCHONCT03544892
The Effects of a Low Carbohydrate, Non-Ketogenic Diet Versus Standard Diabetes Diet on Glycemic Control in Type 1 Diabetes
A study testing Low carbohydrate diet in people with Diabetes Mellitus, Type 1, run by University of Oklahoma at 1 site in United States.
Trial summary
This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Low carbohydrate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 28 Jun 2019
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed Type 1 diabetes for > 1 year confirmed by physician diagnosis
- HbA1c >5.9% and <10%;
- Confirmation of minimum three blood glucose tests per day (meter download or chart record)
- Use of continuous subcutaneous insulin infusion therapy (CSII) or multiple daily injection (MDI) intensive insulin therapy
- No change in insulin therapy type (CSII or MDI) in last 2 months or longer
- Willingness to count carbohydrate and use bolus calculator on insulin pump during the intervention periods
- Willingness to wear a 7 day CGM at three different time points during the study
Who cannot join
- Females of childbearing potential who are pregnant or intend to become pregnant, are exclusively breastfeeding, or who are not using adequate contraceptive methods
- Use of corticosteroids during or within 30 days prior to the intervention periods
- Macroalbuminuria
- Active proliferative retinopathy combined with an HbA1c ≥ 9%
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Harold Hamm Diabetes Center
Tulsa, Oklahoma, 74135
About this study
This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). This study will be used to inform clinical practice, especially in teaching medical nutrition therapy to new-onset diabetes patients and those struggling with glycemic control and hyperlipidemia. At this time, no evidenced-based universal recommendations from randomized controlled trials exist to support low carbohydrate dietary patterns as a front-line approach in individuals with T1D. The investigators hypothesize a diet consisting of 60-80 g carbohydrate diet will result in greater improvement in glycemic control compared to a 50% carbohydrate diet in patients with Type 1 diabetes over 12 weeks in the outpatient setting.
Read the detailed description
Type 1 diabetes mellitus (T1D) is marked by total insulin dependence with challenges regarding glycemic control and concomitant sequela. While standard of care medical nutrition therapy for this disease centers on matching carbohydrate to insulin at meals, recent literature and clinical reports have shown superior glycemic control and cardiovascular measures with lower carbohydrate dietary patterns (<130g/day) as compared to the standard American MyPlate (50% total calories as carbohydrate) approach. Diabetes management has evolved tremendously in the last twenty years with the development of sophisticated insulin pumps and continuous glucose monitors; but, glycemic control is still dependent on quantification of carbohydrate, imperfect in the real-world setting. Due to inherent error in carbohydrate counting, the investigators propose that less carbohydrate will produce better glycemic control by minimizing error and subsequent variation in individuals with type 1 diabetes.
There has long been a movement in the medical community to prescribe low carbohydrate diets under the premise of "less carbohydrate, less insulin, less glycemic variation". This strategy centers on "the law of small numbers", a calculus principle describing magnitude of variation in the output (glycemic variation) as the function of input size (CHO + insulin). Carbohydrate counting tends to result in ~50% error while there is ~30% variation in insulin action, making exactitude impossible. However, low CHO diets tend to provide >40% energy from fat due to the macronutrient distribution. With innate risk of cardiovascular disease in T1D, standard of care has supported restriction of total fat consumption, especially saturated fat, in effort to control cholesterol. While the American Diabetes Association recognizes that dietary fat is a controversial and complex issue, eliminating trans-fats is the only consensus point across the field. To date, most low CHO diet studies in both T1D and Type 2 Diabetes (T2D) have not shown adverse effects on lipids and tend to show decreases in triglycerides and either no change or increases in HDL, LDL, and total cholesterol.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Low carbohydrate diet, Standard of care diet
- Keywords
- Low carbohydrate diet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietOther
60-80 g total carbohydrate per day
Standard of care dietOther
> 150 g total carbohydrate per day
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Low carbohydrate diet | Experimental | Not described Receives: Other: Low carbohydrate diet |
| Experimental: Standard of care diet | Active comparator | Not described Receives: Other: Standard of care diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Difference in time spent with glucose values between 70-180 mg/dL assessed by continuous glucose monitoring (CGM)
Measured: 5 days of worn CGM during each intervention
Secondary outcomes (33)
Mean Glucose
Difference in mean glucose values assessed by CGM
Measured: Baseline to 12 weeks (1 week worn CGM data)
Standard deviation of glucose
Difference in standard deviation of glucose values assessed by CGM
Measured: Baseline to 12 weeks (1 week worn CGM data)
Mean amplitude of glycemic excursions
Difference in mean amplitude of glycemic excursions assessed by CGM
Measured: Baseline to 12 weeks (1 week worn CGM data)
Time in hypoglycemia
Difference in time spent with glucose values <70 mg/dL; between 55-70 mg/dL; and <55 mg/dL
Measured: Baseline to 12 weeks (1 week worn CGM data)
Time in hyperglycemia
Difference in time spent with glucose values >180 mg/dL
Measured: Baseline to 12 weeks (1 week worn CGM data)
Change in HbA1c
Difference in change in hemoglobin A1c
Measured: Baseline to 12 weeks
Coefficient of Variation
Estimate of glucose variability calculated by dividing the standard deviation by average glucose
Measured: Baseline to 12 weeks (1 week worn CGM data)
Severe hypoglycemia
Difference in number of severe hypoglycemia episodes (glucagon or IV dextrose administration)
Measured: Baseline to 12 weeks
Total daily insulin dose
Difference in total daily insulin dose
Measured: Baseline to 12 weeks
Total daily basal insulin 24 hour
Difference in total daily basal insulin in 24 hours
Measured: Baseline to 12 weeks
Total daily bolus insulin 24 hour
Difference in total daily bolus insulin in 24 hours
Measured: Baseline to 12 weeks
Body weight
Change in body weight
Measured: Baseline to 12 weeks
Body Mass Index (BMI)
Change in BMI
Measured: Baseline to 12 weeks
Systolic Blood Pressure (mm Hg)
Change in systolic BP
Measured: Baseline to 12 weeks
Diastolic Blood Pressure (mm Hg)
Change in diastolic BP
Measured: Baseline to 12 weeks
Pulse, per minute
Change in pulse
Measured: Baseline to 12 weeks
Energy Intake (kcal/day)
Change in energy intake
Measured: Baseline to 12 weeks
Daily carbohydrate intake (total carbohydrate, g/day)
Change in carbohydrate intake
Measured: Baseline to 12 weeks
Percent energy intake as Carbohydrate
Change in % carbohydrate intake
Measured: Baseline to 12 weeks
Daily protein intake (total protein, g/day) and Daily fat intake (total fat, g/day)
Change in protein intake
Measured: Baseline to 12 weeks
Fat quality intake (% total fat as monounsaturated, polyunsaturated, saturated, omega-3)
Change in fat quality
Measured: Baseline to 12 weeks
Standard Lipid Panel
Change in (Total cholesterol, HDL cholesterol, LDL cholesterol-calculated, triglycerides; mg/dL)
Measured: Baseline to 12 weeks
LDL-P (nmol/L)
Change in LDL-P
Measured: Baseline to 12 weeks
HDL-P (umol/L)
Change in HDL-P
Measured: Baseline to 12 weeks
VLDL-P
Change in VLDL-P (nmol/L)
Measured: Baseline to 12 weeks
LDL size
Change in LDL size (nm)
Measured: Baseline to 12 weeks
HDL size
Change in HDL size (nm)
Measured: Baseline to 12 weeks
VLDL size
Change in VLDL size (nm)
Measured: Baseline to 12 weeks
High-sensitive C-reactive protein (hs-CRP)
Change in hs-CRP
Measured: Baseline to 12 weeks
Plasma lipopolysaccharide
Surrogate marker for inflammation
Measured: Baseline to 12 weeks
Serum Ketones (beta-hydroxybutyrate)
beta-hydroxybutyrate (mmol/L)
Measured: Baseline to 12 weeks
Type 1 Diabetes Nutrition Knowledge Survey
Validated nutrition knowledge survey (nutrition label reading, carbohydrate counting)
Measured: Baseline to Week 33 (end of study)
Diet Quality
Minerals, Vitamins, Dietary Fiber amounts compared to DRIs for age, ascertained by 3 day 24 hour food logs
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 May 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Why it stopped: PI left the University; study will not continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This study uses 33 week randomized, powered study design to measure glycemic control with a low carbohydrate dietary pattern versus standard of care diabetes medical nutrition therapy. Each arm is 12 weeks with an 8 week washout between arms.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina M Crowder, RDN, CNSC, LD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544892
- Sponsor's protocol ID
- 8840
- Acronym
- T1DLoCHO
- Status last verified
- Jan 2020
- First submitted
- 7 May 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Low Carbohydrate, Non-Ketogenic Diet Versus Standard Diabetes Diet on Glycemic Control in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03544892
- Acronym / sponsor ID
- T1DLoCHO / 8840
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left the University; study will not continue.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 4 Jun 2018 (actual)
- 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.
This randomized, crossover nutrition intervention seeks to examine the effects of a non-ketogenic low carbohydrate (CHO) diet (60-80g per day) on glycemic control, lipids, and markers on inflammation in individuals with Type 1 Diabetes (T1D). This study will be used to inform clinical practice, especially in teaching medical nutrition therapy to new-onset diabetes patients and those struggling with glycemic control and hyperlipidemia. At this time, no evidenced-based universal recommendations from randomized controlled trials exist to support low carbohydrate dietary patterns as a front-line approach in individuals with T1D. The investigators hypothesize a diet consisting of 60-80 g carbohydrate diet will result in greater improvement in glycemic control compared to a 50% carbohydrate diet in patients with Type 1 diabetes over 12 weeks in the outpatient setting.
Detailed description
Type 1 diabetes mellitus (T1D) is marked by total insulin dependence with challenges regarding glycemic control and concomitant sequela. While standard of care medical nutrition therapy for this disease centers on matching carbohydrate to insulin at meals, recent literature and clinical reports have shown superior glycemic control and cardiovascular measures with lower carbohydrate dietary patterns (<130g/day) as compared to the standard American MyPlate (50% total calories as carbohydrate) approach. Diabetes management has evolved tremendously in the last twenty years with the development of sophisticated insulin pumps and continuous glucose monitors; but, glycemic control is still dependent on quantification of carbohydrate, imperfect in the real-world setting. Due to inherent error in carbohydrate counting, the investigators propose that less carbohydrate will produce better glycemic control by minimizing error and subsequent variation in individuals with type 1 diabetes.
There has long been a movement in the medical community to prescribe low carbohydrate diets under the premise of "less carbohydrate, less insulin, less glycemic variation". This strategy centers on "the law of small numbers", a calculus principle describing magnitude of variation in the output (glycemic variation) as the function of input size (CHO + insulin). Carbohydrate counting tends to result in ~50% error while there is ~30% variation in insulin action, making exactitude impossible. However, low CHO diets tend to provide >40% energy from fat due to the macronutrient distribution. With innate risk of cardiovascular disease in T1D, standard of care has supported restriction of total fat consumption, especially saturated fat, in effort to control cholesterol. While the American Diabetes Association recognizes that dietary fat is a controversial and complex issue, eliminating trans-fats is the only consensus point across the field. To date, most low CHO diet studies in both T1D and Type 2 Diabetes (T2D) have not shown adverse effects on lipids and tend to show decreases in triglycerides and either no change or increases in HDL, LDL, and total cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses 33 week randomized, powered study design to measure glycemic control with a low carbohydrate dietary pattern versus standard of care diabetes medical nutrition therapy. Each arm is 12 weeks with an 8 week washout between arms.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Low carbohydrate diet | Experimental | Other: Low carbohydrate diet |
| Experimental: Standard of care diet | Active comparator | Other: Standard of care diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Confirmed Type 1 diabetes for > 1 year confirmed by physician diagnosis
- HbA1c >5.9% and <10%;
- Confirmation of minimum three blood glucose tests per day (meter download or chart record)
- Use of continuous subcutaneous insulin infusion therapy (CSII) or multiple daily injection (MDI) intensive insulin therapy
- No change in insulin therapy type (CSII or MDI) in last 2 months or longer
Key exclusion criteria (6 listed)
- Females of childbearing potential who are pregnant or intend to become pregnant, are exclusively breastfeeding, or who are not using adequate contraceptive methods
- Use of corticosteroids during or within 30 days prior to the intervention periods
- Macroalbuminuria
- Active proliferative retinopathy combined with an HbA1c ≥ 9%
- Known or suspected alcohol or drug abuse
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 diet60-80 g total carbohydrate per day | Other | Experimental: Low carbohydrate diet |
| Standard of care diet> 150 g total carbohydrate per day | Other | Experimental: Standard of care diet |
Primary outcome
Time in Range
Time frame: 5 days of worn CGM during each intervention
Difference in time spent with glucose values between 70-180 mg/dL assessed by continuous glucose monitoring (CGM)
33 secondary outcomes
Mean Glucose
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Standard deviation of glucose
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Mean amplitude of glycemic excursions
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Time in hypoglycemia
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Time in hyperglycemia
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Change in HbA1c
Time frame: Baseline to 12 weeks
Coefficient of Variation
Time frame: Baseline to 12 weeks (1 week worn CGM data)
Severe hypoglycemia
Time frame: Baseline to 12 weeks
Total daily insulin dose
Time frame: Baseline to 12 weeks
Total daily basal insulin 24 hour
Time frame: Baseline to 12 weeks
Total daily bolus insulin 24 hour
Time frame: Baseline to 12 weeks
Body weight
Time frame: Baseline to 12 weeks
Body Mass Index (BMI)
Time frame: Baseline to 12 weeks
Systolic Blood Pressure (mm Hg)
Time frame: Baseline to 12 weeks
Diastolic Blood Pressure (mm Hg)
Time frame: Baseline to 12 weeks
Pulse, per minute
Time frame: Baseline to 12 weeks
Energy Intake (kcal/day)
Time frame: Baseline to 12 weeks
Daily carbohydrate intake (total carbohydrate, g/day)
Time frame: Baseline to 12 weeks
Percent energy intake as Carbohydrate
Time frame: Baseline to 12 weeks
Daily protein intake (total protein, g/day) and Daily fat intake (total fat, g/day)
Time frame: Baseline to 12 weeks
Fat quality intake (% total fat as monounsaturated, polyunsaturated, saturated, omega-3)
Time frame: Baseline to 12 weeks
Standard Lipid Panel
Time frame: Baseline to 12 weeks
LDL-P (nmol/L)
Time frame: Baseline to 12 weeks
HDL-P (umol/L)
Time frame: Baseline to 12 weeks
VLDL-P
Time frame: Baseline to 12 weeks
LDL size
Time frame: Baseline to 12 weeks
HDL size
Time frame: Baseline to 12 weeks
VLDL size
Time frame: Baseline to 12 weeks
High-sensitive C-reactive protein (hs-CRP)
Time frame: Baseline to 12 weeks
Plasma lipopolysaccharide
Time frame: Baseline to 12 weeks
Serum Ketones (beta-hydroxybutyrate)
Time frame: Baseline to 12 weeks
Type 1 Diabetes Nutrition Knowledge Survey
Time frame: Baseline to Week 33 (end of study)
Diet Quality
Time frame: Baseline to 12 weeks
Results and safety
The study was stopped early (reason given: PI left the University; study will not continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Christina M Crowder, RDN, CNSC, LD principal investigator
University of Oklahoma
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 in people with Diabetes Mellitus, Type 1, run by University of Oklahoma 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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Jan 2020. 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 was stopped early (reason given: PI left the University; study will not continue.). Results are not available in the source record.
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?
Time in Range (time frame: 5 days of worn CGM during each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.