A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.
Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.
Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.
Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.
Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Los Angeles、California、美国、90022
- Roybal Diabetes Management Clinic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Demographic
- Age >18 years
- Enrolled in the Roybal Diabetes Management Clinic
- Self-described as Hispanic
- Willing and able to participate in Spanish language group sessions.
- Willing and able to attend study visits for the duration of the study at the allocated times.
- Willing and able to maintain a food exercise and medication log and perform and record self-monitoring of blood glucose (SMBG) Clinical
- T2DM diagnosed by fasting blood glucose >126mg/dL or random blood glucose >200mg/dL
- BMI>30 kg/m2
- If a woman of childbearing potential, using effective contraception. Biochemical HbA1c 8%-12% Medication
- On insulin therapy
Exclusion Criteria:
Medical conditions
- Type 1 DM
- Illness likely to lead to unstable weight or altered glucose control.
- Proliferative diabetic retinopathy on eye examination within the last 6 months.
- Gallstones suspected on clinical history or documented on ultrasound.
- Serum creatinine >1.5mg/dL
- Symptomatic cardiovascular disease
- Documented liver disease other than fatty liver
- Lactating, pregnant or intending to become pregnant within the following year Psycho-social conditions
- Inability or unwillingness to participate in a Spanish-language lifestyle group.
- Eating disorder such as bulimia
- Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar disorder.
- Inability to attend scheduled appointments regularly for the duration of the study Medication use
- Use of weight loss medication within previous 3 months including exenatide.
- Use of medication (other than diabetes medication) likely to lead to unstable weight or altered glucose control
- Laxative or substance abuse
- More than 10 alcoholic drinks/week
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:Meal Replacement
Meal Replacements will be provided to participants randomized to the MR group
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5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
其他名称:
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其他:Standard Care
Standard Care participants will receive standard care but no meal replacements
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Standard Care only
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in BMI
大体时间:12months
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12months
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次要结果测量
结果测量 |
大体时间 |
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Severe Hypoglycemic Events
大体时间:12 months
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12 months
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合作者和调查者
调查人员
- 首席研究员:Elizabeth O Beale, MD、University of Southern California
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Meal Replacement的临床试验
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University Hospital, Limoges主动,不招人
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University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne University完全的