Blood Glucose Stability and Variability on Two Diets

Not Applicable

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Dietary Supplement: Usual Diet; Other: Portion-controlled diet

• Registration Number: NCT01443143
• Lead Sponsor: Nutrisystem, Inc.

Brief 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. 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 Timeline

• Study Start: 2010-12
• Status Verified: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Last Update Submitted: 2011-09-27
• Study First Posted: 2011-09-29
• Last Update Posted: 2011-09-29
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Usual Diet	Usual Diet	Participants' usual consumption of food and beverages.
Commercial diet	Portion-controlled diet	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.

Primary Outcome Measures

Name	Time	Method
Percent of time in euglycemic range	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).

Secondary Outcome Measures

Name	Time	Method
AUC	2 weeks	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.
MAGE	2 weeks	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
Mean glucose	2 weeks	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.
SD of glucose values	2 weeks	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.
IQR of blood glucose	2 weeks	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.
Percent of time in hypoglycemic range	2 weeks	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.
Percent of time in hyperglycemic range	2 weeks	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.

Trial Locations

Locations (1)

University of Pennsylvania Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States