The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study

Completed · Not applicable

Conditions studied: Obesity

In brief

The purpose of this research study to find out whether a pre-packaged, portion controlled diet with a group behavior modification program or group diabetes support and education, is a safe and effective way for people with type 2 diabetes to lose weight and manage their diabetes.

Key facts

Study ID

NCT01260337

Run by

Temple University

People needed

100

Starts

2010-03-01

Expected to finish

2011-08-01

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…

• 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 ≥ 6.5 and <12.0.

You may not qualify if…

• Use of Byetta (exenatide) or Symlin (pramlintide acetate) for diabetic control< 6 months. Participants must be stable on all other medications for at least 3 months for inclusion. If a participant is on a medication for less than 3 months and the study physician determines the medications will not affect the study outcomes (weight, glycemic control, etc), they can be enrolled (excluding hypertension or cholesterol medications).
• BMI ≤24.9 or ≥ 50.1
• Participation in another formal weight loss program within last 6 months
• Weight loss > 5 kg during the 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
• History of testing HIV positive
• History of alcohol or drug abuse
• Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
• 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 taking anti-depressants (SSRI's are allowed except for bupropion [Wellbutrin]) , mood stabilizers, anti-psychotics, and psychiatric medications treating any mood, psychological or psychiatric condition. Refer to Appendix 1 for medication exclusion list.
• Participants with screening triglycerides above 500 mg
• Uncontrolled Dyslipidemia as defined by screening LDL cholesterol of ≥ 160 mg/dL. Participants on medication treating dyslipidemia for at least 3 months are allowable.
• Any female who tests positive on a urine pregnancy test or who reports being pregnant at screening
• Gastrointestinal Disorders (gallbladder disease, Crohn's disease, Irritable bowel syndrome, and any GI disease that affects malabsorption).
• An allergy to certain foods that cannot be avoided due to the nature of the packaged foods such as, but not limited to nuts, dairy, gluten, etc.
• Non-medical related dietary restrictions, such as vegetarians
• Neuropathy that interferes with exercise.
• Smoking or tobacco use
• Previous weight loss surgery.

Where it is running

• University of Pennsylvania, Center for Weight and Eating Disorders — Philadelphia, Pennsylvania, United States
• Temple University, The Center for Obesity Research and Education — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.