NCT01601574已完成3 期
Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 28
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant reported diagnosis of Type II diabetes
- •HbA1c between 7%-11% (inclusive)
- •Fasting blood glucose <
- •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 -
排除标准
- •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 -
结局指标
主要结局
Change in HbA1c
时间窗: Baseline and 12 months
次要结局
- Secondary Endpoints(Baseline and 12 months)
研究者
研究点 (28)
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