Clinical trial NCT00729196: A Trial of Two Diets for Weight and Diabetes Management
Official title: A Trial of Two Diets for Weight and Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: Obesity
Type 2 Diabetes
Glycemic Load
Weight Loss
Glycated Hemoglobin
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 2008-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a low-fat or low-glycemic load diet is more effective for controlling weight and blood glucose in persons with type 2 diabetes.

Detailed description: This research is a randomized controlled trial to compare long-term outcomes behavioral weight loss interventions that include either low-fat or low-glycemic load dietary instruction. Targets for energy intake and expenditure, and behavioral skills taught, are identical across the two diets. Additionally, both treatments include 20 weekly group sessions, followed by 10 every-other-week sessions. Participants are overweight and obese adults with type 2 diabetes. The primary outcomes are changes in weight and glycated hemoglobin. Those randomized to the low-glycemic load diet are expected to achieve greater weight losses and maintain better glycemic control at the end of treatment (i.e., week 40) and after 1 year of no-treatment follow-up (i.e., week 92).

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Body mass index (BMI) of 27 to 45 kg/m2 with weight \</= 136 kg (300 lbs.
* Capacity to provide written informed consent
* Systolic blood pressure between 90 and 160 mm Hg, inclusive.
* Diastolic blood pressure between 65 and 100 mm Hg, inclusive.
* Resting heart rate between 65 and 90 beats per minute, inclusive.

Exclusion Criteria:

* a recent (i.e., within 1 year) myocardial infarction
* unstable angina
* malignant arrhythmias
* history of cerebrovascular, renal, or hepatic disease
* history of seizures
* protein wasting diseases (e.g., Cushing's syndrome)
* uncontrolled hypertension (\> 160/100 mm Hg)
* type 1 diabetes
* uncontrolled thyroid disease
* pregnancy or lactation
* electrolyte abnormalities
* clinically significant psychosocial impairment (principally, major depression)
* treatment with steroids

Primary outcomes:
measure: Percent change in weight
timeFrame: 92 weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: 92 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anthony N Fabricatore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Thomas A Wadden, Ph.D.
role: STUDY_DIRECTOR
affiliation: Children's Hospital of Philadelphia
name: Virginia A Stallings, M.D.
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Stanley Schwartz, M.D.
role: STUDY_DIRECTOR
References: