Clinical trial NCT01345500: UCSD Take Charge Study
Official title: Randomized Clinical Trial of a Weight Loss Program in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Obesity
Diabetic
Type 2 Diabetes
Keywords: Overweight
Obese
Type 2 Diabetic
Diabetes
Weight loss
Physical activity
Diet
Prepackaged meals
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: HealthPartners Institute
name: University of Minnesota
First posted: 2011-05-02
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the Take Charge Study is to determine among overweight and obese men and women with type 2 diabetes whether 1) participating in a commercial weight loss program promotes great weight loss and weight loss maintenance at one year compared to usual care conditions and 2) whether there is a differential weight loss response to different dietary macronutrient composition (lower carbohydrate/higher fat diet versus a higher carbohydrate/lower fat).


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Type 2 diabetes
* BMI 25-45 kg/m2
* Willing to participate in any of the study diet arms (higher or lower carbohydrate diet or usual care) over a one-year period
* Able to comply with all required study procedures and schedule
* Must live within the San Diego or Minneapolis area

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant in the next year
* Serious medical condition or psychiatric illness
* History of having an eating disorder, food allergy or food intolerance
* Have food restrictions or requires a special diet
* Objects to frozen, processed or prepackaged foods
* Inability to be moderately physically active
* Currently enrolled in a weight loss program or another diet intervention
* Current use of weight loss medication or supplements
* Planned surgical procedure that can impact the conduct of the study
* Previous surgical procedures for weight reduction
* Does not have own transportation
* Have plans to relocate from area within 1 year
* HbA1C \>11%, fasting triglycerides \>600 mg/dL, serum creatinine \>1.4 mg/dL (women) or 1.5 mg/dL (men) -- to be screened at baseline visit

Primary outcomes:
measure: Total weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Response to macronutrient composition
timeFrame: 1 year
measure: Biochemical/social outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Minneapolis
country: United States
facility: HealthPartners Research Foundation and University of Minnesota
state: Minnesota
Study officials:
affiliation: University of California, San Diego
name: Cheryl L Rock, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rock CL, Flatt SW, Pakiz B, Taylor KS, Leone AF, Brelje K, Heath DD, Quintana EL, Sherwood NE. Weight loss, glycemic control, and cardiovascular disease risk factors in response to differential diet composition in a weight loss program in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1573-80. doi: 10.2337/dc13-2900. Epub 2014 Apr 23.