Efficacy of 2 Diet Plans Designed for People With Type II Diabetes on Weight and Health Measures

NCT00198757 | Completed

• 1 other identifier: MEDI2002-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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 women over an 86 week active weight loss and weight maintenance program. There will be up to 34 weeks active weight loss and 52 weeks weight maintenance. The planned sample size is 80 overweight (BMI 25-40) males and females aged 18-65 with type 2 diabetes. It is anticipated that pre-packaged meal replacements will provide an advantage to those desiring weight loss.

Conditions

Obesity; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Body weight (change from baseline through attaining goal or week 34,

• at 26 weeks of maintenance,

• at 52 weeks of maintenance

Secondary Outcomes (4)

• percent body fat (at baseline vs. at attainment of goal weight or at week 34, and at weeks 26 and 52 of maintenance,

• blood pressure,

• blood values including hemoglobin A1C, glucose, cholesterol, and triglycerides;

• changes in medication costs and health related quality of life.

Interventions

Medifast Plus for Diabetics Meal Replacement Supplements BEHAVIORAL

Standard ADA recommended diet for type 2 diabetics BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Medifast, Inc.: collaborator

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Lawrence J Cheskin, MD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2002
• Study Completion: January 1, 2005
• Last Updated: September 20, 2005

Record last verified: 2005-05