UCSD Take Charge Study

University of California San Diego

Status: Completed

Conditions: Diabetic; Obese; Overweight; Obesity; Type 2 Diabetes

Treatments: Other: Lower carbohydrate, Higher fat diet; Other: Individualized Counseling; Other: Higher Carbohydrate, Lower Fat Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01345500

110463

Details and patient eligibility

About

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).

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

227 participants in 3 patient groups

Higher Carbohydrate/Lower Fat Diet

Experimental group

Treatment:

Other: Higher Carbohydrate, Lower Fat Diet

Lower Carbohydrate/Higher Fat Diet

Experimental group

Treatment:

Other: Lower carbohydrate, Higher fat diet

Individualized Counseling

Active Comparator group

Treatment:

Other: Individualized Counseling