Blood Glucose Stability and Variability on Two Diets

NCT01443143 | Unknown

• 1 other identifier: SPO-2010-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Obesity

Keywords

Diabetes; Obesity; Glycemic; Portion-control; Commercial diet

Outcome Measures

Primary Outcomes (1)

• 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).

  2 weeks

Secondary Outcomes (7)

• AUC

  2 weeks

• MAGE

  2 weeks

• Mean glucose

  2 weeks

• SD of glucose values

  2 weeks

• IQR of blood glucose

  2 weeks

Study Arms (2)

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.

Other: Portion-controlled diet

Usual Diet

NO INTERVENTION

Participants' usual consumption of food and beverages.

Dietary Supplement: Usual Diet

Interventions

Portion-controlled diet OTHER

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.

Also known as: Nutrisystem D

Commercial diet

Usual Diet DIETARY_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."

Usual Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nutrisystem, Inc.: lead
• University of Pennsylvania: collaborator

Study Sites (1)

University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 190104, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas A Wadden, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 29, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 29, 2011

Record last verified: 2011-09

Locations

US (1)