Type 2 DiabetesNCT01443143
Blood Glucose Stability and Variability on Two Diets
A study testing Usual Diet in people with Type 2 Diabetes and Obesity, run by Nutrisystem, Inc. at 1 site in United States.
Trial summary
This investigation will examine the effects of consuming a structured, portion-controlled, low-glycemic index diet (commercially available as the Nutrisystem-D program) on several indicators of glycemic stability and variability among participants with 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, Obesity
- What is being tested?
- Usual Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2011
- 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
- Body mass index (BMI) of 27 to 45 kg/m2
- Capacity to provide written informed consent
- Willing and committed to return for all clinic visits and complete all study-related procedures
- Men and women of all racial and ethnic groups are eligible for participation
Who cannot join
- Use of hypoglycemic medications (e.g., sulfonylureas, insulin)
- Food allergies or intolerances that would render adherence to the test diets unpleasant or unsafe
- Use of anticoagulant medications (e.g., warfarin)
- Pregnant or lactating
- More than a 5% weight gain or loss within the last 3 months
- More than one alcoholic drink per day
- Binge eating disorder
- Regular use of acetaminophen
Trial locations and contacts
1 site in 1 country.
L contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 190104
Dana Tioxon, 215-573-7520, tida@mail.med.upenn.edu
Louise Hesson, CRNP, 215-898-7314, lhesson@mail.med.upenn.edu
About this study
Official title: A Comparison of Glycemic Stability and Variability During Consumption of Usual Diet or a Commercially Available Portion-controlled Diet Among Patients With Type 2 Diabetes
This investigation will examine the effects of consuming a structured, portion-controlled, low-glycemic index diet (commercially available as the Nutrisystem-D program) on several indicators of glycemic stability and variability among participants with type 2 diabetes. Results on the portion-controlled diet will be compared with those on participants' usual diets in a randomized cross-over trial. The investigators expect that participants will exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the Nutrisystem D program, as compared with their usual diet.
Read the detailed description
This study will investigate glycemic stability and variability in response to two diets: usual diet and a commercially available portion-controlled diet. The commercially available diet will be the Nutrisystem-D program, which consists of pre-packaged meals and snacks that are supplemented with grocery items, including fruits, vegetables, and dairy items. This trial will be a randomized cross-over trial of 15 patients with type 2 diabetes (weight stable for at least 3 months prior and medication stable throughout the trial). Participants will consume each diet for a 2-week period. During each diet period, participants will wear a blinded (i.e., providing no feedback) continuous glucose monitoring (CGM) device to assess glycemic stability and variability, and will be instructed to keep a detailed record of food and beverage intake and physical activity. The two diet/assessment periods will be separated by a 1-week washout period during which no dietary instruction will be given and no outcomes will be measured. Laboratory values (HbA1c, glucose, insulin, lipid panel) and physical measures (height, weight, waist circumference, blood pressure) will be assessed at the baseline for descriptive purposes.
Primary Hypothesis: A significantly greater percentage of CGM readings will fall in the euglycemic range (71-180 mg/dl) during consumption of the Nutrisystem-D program, as compared with Usual Diet.
Secondary Hypothesis: Participants will have significantly smaller areas under the curve, mean amplitude of glycemic excurisions, mean, standard deviation, and interquartile range of glucose values, and a smaller of percentage of values in the hypo- (</= 70 mg/dl) and hyperglycemic (>180 mg/dl) ranges during consumption of the Nutrisystem-D program, as compared with Usual Diet.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Portion-controlled diet, Usual Diet
- Keywords
- Diabetes, Obesity, Glycemic, Portion-control, Commercial diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portion-controlled dietOther
Also called Nutrisystem D
During this diet period, participants will consume portion-controlled products from the Nutrisystem-D program for three entrees and one (women) or two (men) snacks per day. These pre-packaged portion-controlled items will be supplemented with grocery additions (fruits, vegetables, and low-fat dairy items) to provide approximately 1300 (women) to 1500 (men) calories per day. The Nutrisystem-D program (i.e., provided foods plus grocery additions) provides approximately 53% of calories from carbohydrate, 22% of calories from fat (6% from saturated fat and 0% from trans fat), and 25% of calories from protein. Women and men on the program consume approximately 1800 and 2000 mg/d, respectively, of sodium, and 31 and 35 g/d, respectively, of fiber.
Usual DietDietary supplement
During the usual diet period, participants will not be given any specific instructions about what they should or should not consume. Instead, they will be told to "Eat how you would normally eat if you were not in this study."
| Study group | Role | What they receive |
|---|---|---|
| Commercial diet | Experimental | Commercially available diet program (i.e., Nutrisystem D) that includes pre-packaged low-glycemic index portion-controlled entrees and snacks that are supplemented with grocery items in accordance with a structured meal plan. Receives: Other: Portion-controlled diet |
| Usual Diet | No intervention | Participants' usual consumption of food and beverages. Receives: Dietary Supplement: Usual Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of time in euglycemic range
Euglycemia will be defined as a CGM reading in the range of 71-180 mg/dl, inclusive. Percent of time in the euglycemic range each day is automatically generated by the software accompanying the CGM device. Daily values will be averaged over each of the 2-week assessment periods (i.e. during consumption of Usual Diet or Nutrisystem-D program).
Measured: 2 weeks
Secondary outcomes (7)
AUC
Area under the curve (AUC) for glucose will be calculated (using the trapezoidal method) for each day of monitoring and averaged over each of the 2-week assessment periods.
Measured: 2 weeks
MAGE
Mean amplitude of glycemic excursions(MAGE) will be calculated (using methods described by Service et al.) for each day of monitoring and averaged over each of the 2-week assessment periods
Measured: 2 weeks
Mean glucose
Daily values for mean blood glucose will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Measured: 2 weeks
SD of glucose values
The daily standard deviation (SD) of blood glucose values will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Measured: 2 weeks
IQR of blood glucose
The daily interquartile range(IQR) of blood glucose values will be automatically generated by the software that accompanies the CGM device. These daily values will be averaged over each of the 2-week assessment periods.
Measured: 2 weeks
Percent of time in hypoglycemic range
Daily values for percent of time in the hypoglycemic range (< 70 mg/dl) will be automatically generated by the software that accompanies the CGM device. Daily values will be averaged over each of the 2-week assessment periods.
Measured: 2 weeks
Percent of time in hyperglycemic range
Daily values for percent of time in the hyperlycemic range (>/= 180 mg/dl) will be automatically generated by the software that accompanies the CGM device. Daily values will be averaged over each of the 2-week assessment periods.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrisystem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Thomas A Wadden, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443143
- Sponsor's protocol ID
- SPO-2010-02
- Status last verified
- Sep 2011
- First submitted
- 26 Sep 2011
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Glycemic Stability and Variability During Consumption of Usual Diet or a Commercially Available Portion-controlled Diet Among Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01443143
- Acronym / sponsor ID
- SPO-2010-02
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Diabetes, Obesity, Glycemic, Portion-control, Commercial diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nutrisystem, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Pennsylvania
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Sep 2011 (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.
This investigation will examine the effects of consuming a structured, portion-controlled, low-glycemic index diet (commercially available as the Nutrisystem-D program) on several indicators of glycemic stability and variability among participants with type 2 diabetes. Results on the portion-controlled diet will be compared with those on participants' usual diets in a randomized cross-over trial. The investigators expect that participants will exhibit greater glycemic stability (e.g., more time in euglycemic range) and less glycemic variability (e.g., smaller mean amplitude of glycemic excursions) while consuming the Nutrisystem D program, as compared with their usual diet.
Detailed description
This study will investigate glycemic stability and variability in response to two diets: usual diet and a commercially available portion-controlled diet. The commercially available diet will be the Nutrisystem-D program, which consists of pre-packaged meals and snacks that are supplemented with grocery items, including fruits, vegetables, and dairy items. This trial will be a randomized cross-over trial of 15 patients with type 2 diabetes (weight stable for at least 3 months prior and medication stable throughout the trial). Participants will consume each diet for a 2-week period. During each diet period, participants will wear a blinded (i.e., providing no feedback) continuous glucose monitoring (CGM) device to assess glycemic stability and variability, and will be instructed to keep a detailed record of food and beverage intake and physical activity. The two diet/assessment periods will be separated by a 1-week washout period during which no dietary instruction will be given and no outcomes will be measured. Laboratory values (HbA1c, glucose, insulin, lipid panel) and physical measures (height, weight, waist circumference, blood pressure) will be assessed at the baseline for descriptive purposes.
Primary Hypothesis: A significantly greater percentage of CGM readings will fall in the euglycemic range (71-180 mg/dl) during consumption of the Nutrisystem-D program, as compared with Usual Diet.
Secondary Hypothesis: Participants will have significantly smaller areas under the curve, mean amplitude of glycemic excurisions, mean, standard deviation, and interquartile range of glucose values, and a smaller of percentage of values in the hypo- (</= 70 mg/dl) and hyperglycemic (>180 mg/dl) ranges during consumption of the Nutrisystem-D program, as compared with Usual Diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercial diet | Experimental | Other: Portion-controlled dietCommercially available diet program (i.e., Nutrisystem D) that includes pre-packaged low-glycemic index portion-controlled entrees and snacks that are supplemented with grocery items in accordance with a structured meal plan. |
| Usual Diet | No intervention | Dietary Supplement: Usual DietParticipants' usual consumption of food and beverages. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 2 diabetes
- Body mass index (BMI) of 27 to 45 kg/m2
- Capacity to provide written informed consent
- Willing and committed to return for all clinic visits and complete all study-related procedures
- Men and women of all racial and ethnic groups are eligible for participation
Key exclusion criteria (8 listed)
- Use of hypoglycemic medications (e.g., sulfonylureas, insulin)
- Food allergies or intolerances that would render adherence to the test diets unpleasant or unsafe
- Use of anticoagulant medications (e.g., warfarin)
- Pregnant or lactating
- More than a 5% weight gain or loss within the last 3 months
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 |
|---|---|---|
| Portion-controlled dietAlso: Nutrisystem DDuring this diet period, participants will consume portion-controlled products from the Nutrisystem-D program for three entrees and one (women) or two (men) snacks per day. These pre-packaged portion-controlled items will be supplemented with grocery additions (fruits, vegetables, and low-fat dairy items) to provide approximately 1300 (women) to 1500 (men) calories per day. The Nutrisystem-D program (i.e., provided foods plus grocery additions) provides approximately 53% of calories from carbohydrate, 22% of calories from fat (6% from saturated fat and 0% from trans fat), and 25% of calories from protein. Women and men on the program consume approximately 1800 and 2000 mg/d, respectively, of sodium, and 31 and 35 g/d, respectively, of fiber. | Other | Commercial diet |
| Usual DietDuring the usual diet period, participants will not be given any specific instructions about what they should or should not consume. Instead, they will be told to "Eat how you would normally eat if you were not in this study." | Dietary supplement | Usual Diet |
Primary outcome
Percent of time in euglycemic range
Time frame: 2 weeks
Euglycemia will be defined as a CGM reading in the range of 71-180 mg/dl, inclusive. Percent of time in the euglycemic range each day is automatically generated by the software accompanying the CGM device. Daily values will be averaged over each of the 2-week assessment periods (i.e. during consumption of Usual Diet or Nutrisystem-D program).
7 secondary outcomes
AUC
Time frame: 2 weeks
MAGE
Time frame: 2 weeks
Mean glucose
Time frame: 2 weeks
SD of glucose values
Time frame: 2 weeks
IQR of blood glucose
Time frame: 2 weeks
Percent of time in hypoglycemic range
Time frame: 2 weeks
Percent of time in hyperglycemic range
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
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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.
L contact
Thomas A Wadden, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Diet in people with Type 2 Diabetes and Obesity, run by Nutrisystem, Inc. 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Sep 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of time in euglycemic range (time frame: 2 weeks). 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 29 Sep 2011.