Blood Glucose Stability and Variability on Two Diets

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Nutrisystem, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Nutrisystem, Inc.
ClinicalTrials.gov Identifier:
NCT01443143
First received: September 26, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Obesity
Other: Portion-controlled diet
Dietary Supplement: Usual Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nutrisystem, Inc.:

Primary Outcome Measures:
  • Percent of time in euglycemic range [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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:
  • AUC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Commercial 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.
Other: Portion-controlled diet
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.
Other Name: Nutrisystem D
No Intervention: Usual Diet
Participants' usual consumption of food and beverages.
Dietary Supplement: Usual Diet
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."

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443143

Contacts
Contact: L

Locations
United States, Pennsylvania
University of Pennsylvania Center for Weight and Eating Disorders Recruiting
Philadelphia, Pennsylvania, United States, 190104
Contact: Dana Tioxon    215-573-7520    tida@mail.med.upenn.edu   
Contact: Louise Hesson, CRNP    215-898-7314    lhesson@mail.med.upenn.edu   
Principal Investigator: Thomas A Wadden, Ph.D.         
Sub-Investigator: Marion L Vetter, MD         
Sponsors and Collaborators
Nutrisystem, Inc.
University of Pennsylvania
Investigators
Principal Investigator: Thomas A Wadden, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Nutrisystem, Inc.
ClinicalTrials.gov Identifier: NCT01443143     History of Changes
Other Study ID Numbers: SPO-2010-02
Study First Received: September 26, 2011
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nutrisystem, Inc.:
Diabetes
Obesity
Glycemic
Portion-control
Commercial diet

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014