Weight Loss Study for People With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Type 2 Diabetes, Overweight, Obesity

In brief

The purpose of this study is to determine whether the Weight Watchers program modified for use by people with Type 2 diabetes results in more improvements in blood glucose control relative to a control group receiving standard diabetes counseling.

Key facts

Study ID

NCT01601574

Run by

Medical University of South Carolina

People needed

563

Starts

2012-05-01

Expected to finish

2014-09-01

Last updated by the study team

2014-10-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant reported diagnosis of Type II diabetes
• HbA1c between 7%-11% (inclusive)
• Fasting blood glucose < 240. If a potential participant has a FBG above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test.
• BMI 27-50 kg/m2 (inclusive)
• Age range - 18 - 70 (inclusive)
• Clearance on medical exam by study physician including EKG
• No weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
• On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• All diabetes medications are permitted including insulin.
• Willing and able to commit to regular physical activity (e.g. walking) five days per week
• Willingness and ability to make all scheduled appointments required by study protocol
• Willingness to attend weekly Weight Watchers meetings in the community and to participate in Weight Watchers online program, if so randomized
• Willing to follow requirements of study protocol
• Willing and able to provide a valid email address for use in the study
• Must be able to communicate (oral and written) in English
• Under the care of a physician for diabetes and willing to give release to contact the MD and request MD's agreement for participant to participate -

You may not qualify if…

• Type 1 Diabetes
• Cardiovascular/Coronary Heart Disease [e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative]
• Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
• Taking prescription or OTC weight loss medications within last 4 weeks
• Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
• Within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. Participants using other non-excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
• Participation in a weight control program within the past 3 months
• QTc interval >450 msec for males and QTc interval >470 msec for females
• PHQ-9 total score > 15
• Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
• History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
• History of major surgery within three months of enrollment
• Presence of implanted cardiac defibrillator
• Orthopedic limitations that would interfere with ability to engage in regular physical activity
• Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
• Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
• History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
• Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
• Participation in another clinical trial within 30 days prior to enrollment.
• Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
• Current or past drug abuse
• Participation in trial by another member of household
• Hypoglycemic Events:
• a. Evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
• Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -

Where it is running

• Diabetes Research and Training Center, University of Alabama at Birmingham — Birmingham, Alabama, United States
• Scripps Clinical Research — La Jolla, California, United States
• CSRA Partners in Health — Augusta, Georgia, United States
• Northwestern University Feinberg School — Chicago, Illinois, United States
• Obesity Research Center St. Luke's Roosevelt Hospital Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Center for Nutrition and Preventive Medicine — Charlotte, North Carolina, United States
• Obesity Clinical Trials Program Duke University Medical Center — Durham, North Carolina, United States
• Your Diabetes Endocrine Nutrition Group Inc. — Mentor, Ohio, United States
• Oregon Weight Loss Surgery, LLC — Portland, Oregon, United States
• The University of Pennsylvania Center for Weight and Eating Disorders — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor Endocrine Center — Dallas, Texas, United States
• Oakwell Clinical Research — San Antonio, Texas, United States
• Washington Center for Weight Management & Research, Inc The Navy League Building — Arlington, Virginia, United States

Full record on ClinicalTrials.gov

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