Clinical trial NCT01601574: Weight Loss Study for People With Type 2 Diabetes
Official title: Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Overweight
Obesity
Keywords: Type 2 diabetes
HbA1c
Overweight
Obesity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2012-05-18
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participant reported diagnosis of Type II diabetes
2. HbA1c between 7%-11% (inclusive)
3. 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.
4. BMI 27-50 kg/m2 (inclusive)
5. Age range - 18 - 70 (inclusive)
6. Clearance on medical exam by study physician including EKG
7. No weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
8. On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
9. All diabetes medications are permitted including insulin.
10. Willing and able to commit to regular physical activity (e.g. walking) five days per week
11. Willingness and ability to make all scheduled appointments required by study protocol
12. Willingness to attend weekly Weight Watchers meetings in the community and to participate in Weight Watchers online program, if so randomized
13. Willing to follow requirements of study protocol
14. Willing and able to provide a valid email address for use in the study
15. Must be able to communicate (oral and written) in English
16. 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 -

Exclusion Criteria:

1. Type 1 Diabetes
2. Cardiovascular/Coronary Heart Disease \[e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative\]
3. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
4. Taking prescription or OTC weight loss medications within last 4 weeks
5. Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
6. 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.
7. Participation in a weight control program within the past 3 months
8. QTc interval \>450 msec for males and QTc interval \>470 msec for females
9. PHQ-9 total score \> 15
10. 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
11. 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)
12. History of major surgery within three months of enrollment
13. Presence of implanted cardiac defibrillator
14. Orthopedic limitations that would interfere with ability to engage in regular physical activity
15. Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
16. 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.
17. History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
18. Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
19. Participation in another clinical trial within 30 days prior to enrollment.
20. 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
21. Current or past drug abuse
22. Participation in trial by another member of household
23. 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.
24. 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 -

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
measure: Secondary Endpoints
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Diabetes Research and Training Center, University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinical Research
state: California
city: Augusta
country: United States
facility: CSRA Partners in Health
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School
state: Illinois
city: New York
country: United States
facility: Obesity Research Center St. Luke's Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Charlotte
country: United States
facility: Center for Nutrition and Preventive Medicine
state: North Carolina
city: Durham
country: United States
facility: Obesity Clinical Trials Program Duke University Medical Center
state: North Carolina
city: Mentor
country: United States
facility: Your Diabetes Endocrine Nutrition Group Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Weight Loss Surgery, LLC
state: Oregon
city: Philadelphia
country: United States
facility: The University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical Research
state: Texas
city: Arlington
country: United States
facility: Washington Center for Weight Management & Research, Inc The Navy League Building
state: Virginia
Study officials:
affiliation: Medical University of South Carolina
name: Patrick M. O'Neil, PhD
role: STUDY_DIRECTOR
References:
citation: O'Neil PM, Miller-Kovach K, Tuerk PW, Becker LE, Wadden TA, Fujioka K, Hollander PL, Kushner RF, Timothy Garvey W, Rubino DM, Malcolm RJ, Weiss D, Raum WJ, Salyer JL, Hermayer KL, Rost SL, Veliko JL, Sora ND. Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes. Obesity (Silver Spring). 2016 Nov;24(11):2269-2277. doi: 10.1002/oby.21616.