Pilot Study to Assess Pre-packaged, Portion-controlled Meal Plan on Weight Loss

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion controlled meal plan on weight loss and glycemic control in overweight and obese patients with type 2 diabetes. Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes. The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The study will be powered to detect between group differences of 3% of body weight. Secondarily, the researchers will assess whether there are any differences in weight during the secondary phase from weeks 13-24 when both groups will consume a PCD diet. Aim 2 - Effects on Glycemic Control Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes. The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a DSE group at 12 weeks. The study will be powered to detect between group differences of .5% in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both groups are consuming a PCD will be assessed.

Key facts

Study ID: NCT00593476
Run by: Temple University
People needed: 50
Starts: 2007-03-01
Expected to finish: 2009-03-01
Last updated by the study team: 2013-07-01

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participants must meet all of the following criteria.
Type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
BMI ≥ 25 and ≤ 50
Subjects must be willing to comply with all study-related procedures
Participant with screening HbA1C ≥ 6.0

You may not qualify if…

If participants meet one of the following criteria they will be excluded.
Use of insulin or other pharmaceutical agent for diabetic control other than thiazolidinedione (TZD), Sulfonylurea's, or Metformin or a combination of medications.
BMI ≤ 24.9 or ≥ 50.1
Participation in another formal weight loss program within last 6 months
Participation in Diabetes Support and Education Program or other formal diabetes education program within last 6 months
Uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmHg). Participants on medication treating hypertension for at least three months are allowable.
Known atherosclerotic cardiovascular disease
History of congestive heart failure
History of a non-skin malignancy within the previous 5 years
Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
Detailed Disease and Lab Value Exclusions:
Active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (> 2 weeks) immune modulating/suppressing medications.
Active pulmonary disease will be defined as any patient who has a history of, or currently requires, daily oral corticosteroids, leukotriene inhibitors, an oxygen requirement, or ventilation support for chronic disease management.
Active hepatic disease: defined as any patient who currently, or has a history of requiring immune modulating/suppressing medications, ammonia lowering medications, or hepatic disease related diet modifications.
Active renal disease: defined as any patient who currently, or has a history requiring potassium phosphate lowering medications, protein restriction diet, or hemo/peritoneal dialysis.
Lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (Sodium, potassium, chloride, bicarbonate, BUN, creatinine.)
History of testing HIV positive
History of alcohol or drug abuse
Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
Weight loss > 5 kg during the last 6 months
Participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Participants with screening triglycerides above 500 mg
Anyone that is physically active for ≥ 30 minutes per day as assessed in clinical interview at the screening visit
Uncontrolled Dyslipidemia. Participants stable on medication treating dyslipidemia for at least 3 months or more is allowable.

Where it is running

Jeanes Hospital Medical Office Building — Philadelphia, Pennsylvania, United States
Center for Obesity Research and Education — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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