Status:
COMPLETED
Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Medifast, Inc.
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the efficacy of Medifast Plus for Diabetics compared to a standard weight loss treatment program, in terms of changes in weight loss in overweight men and wo...
Detailed Description
This study will test the efficacy of Medifast Plus for Diabetics compared to a standard American Diabetes Association (ADA) weight loss treatment program using whole foods in 80 participants (randomiz...
Eligibility Criteria
Inclusion
- Age 18-65 years of age.
- Overweight (Body Mass Index between 25-40) and desiring weight loss
- Normal ECG (electrocardiogram) or abnormalities deemed medically acceptable (no acute ischemic changes or V-tach, eg)
- Not using appetite-affecting medications (e.g., Prozac or other SSRIs, synthroid, steroids) unless on established and stable dose
- Not using weight loss drugs (phentermine, sibutramine, orlistat, eg)
- Willing and able to comply with the protocol requirements
- Willing and able to give informed consent
- Have a regular source of health care and permission of primary care provider
- Using an acceptable method of birth control (tubal ligation, abstinence, properly used condom or diaphragm, oral or implanted contraceptives, or intrauterine device) for women of childbearing potential
Exclusion
- Chronic uncontrolled health problems (not including obesity and diabetes). Participants may not have bulimia, laxative abuse, substance abuse, alcohol intake \> 10 drinks per week, or have an uncontrolled psychiatric disorder (major depression, bipolar disorder, etc), as determined at screening
- Breast-feeding or pregnant at screening by serum pregnancy test if female of childbearing capacity. To be considered not childbearing potential, participant must be at least one year post-menopausal or surgically sterile
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00198757
Start Date
July 1 2002
End Date
January 1 2005
Last Update
September 20 2005
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