Blood Glucose Stability and Variability on Two Diets
Status unconfirmed · Not applicable
Conditions studied: Type 2 Diabetes, Obesity
In brief
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.
Key facts
- Study ID
- NCT01443143
- Run by
- Nutrisystem, Inc.
- People needed
- 15
- Starts
- 2010-12-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2011-09-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania Center for Weight and Eating Disorders — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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