Status:
COMPLETED
The Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control: A Comparison Study
Lead Sponsor:
Temple University
Collaborating Sponsors:
Nutrisystem, Inc.
University of Pennsylvania
Conditions:
Obesity
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 effecti...
Detailed Description
Eligible volunteers are randomly assigned to a treatment group consisting of a pre-packaged, portion controlled meal plan plus a group behavior modification program or to a control group that consists...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01260337
Start Date
March 1 2010
End Date
August 1 2011
Last Update
July 1 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania, Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, United States, 19104
2
Temple University, The Center for Obesity Research and Education
Philadelphia, Pennsylvania, United States, 19140