Weight Loss Study for People With Type 2 Diabetes

Obesity Clinical Trial

— T2D  

Official title:

Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601574
• Other study ID #: WW-MUSC-1201
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2012
• Last updated: October 14, 2014
• Start date: May 2012
• Est. completion date: September 2014

Study information

• Verified date: March 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type 2 Diabetes

Intervention

Behavioral:
• Weight Watchers modified program
Weight Watchers: For people with Type 2 diabetes including (1) weekly standard in-person Weight Watchers meetings, (2) use of the standard Weight Watchers online program and tools, and (3) two scheduled telephone consultations with a Certified Diabetes Educator (CDE) who will assist the participant in tailoring the standard Weight Watchers program to accommodate the participant's diabetes-related status, with additional unlimited phone and email access to CDEs at the participant's request

Other:
• Standard Care group
One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in weight	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in BMI	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in waist circumference	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in fasting blood glucose	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in HOMA	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein)	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in diabetes medications.	Baseline and 12 months	No
Secondary	Secondary Endpoints	Change in various mental health assessments	Baseline and 12 months	No

External Links

•   Baylor Health
•   Baylor Research
•   Comprehensive Weight Control Program Weill Medical College of Cornell University
•   Medical University of South Carolina
•   Oakwell Clinical Research
•   Obesity Clinical Trials Program Duke University Medical Center
•   Oregon Weight Loss Surgery, LLC
•   Scripps Nutrition and Metabolic & Research
•   The University of Pennsylvania Center for Weight and Eating Disorders
•   The Washington Center for Weight Management & Research
•   University of Alabama at Birmingham Department of Nutrition
•   Your Diabetes Endocrine Nutrition Group, Inc