A Pilot Study to Assess the Effects of a Pre-packaged, Portion Controlled Meal Plan on Type 2 Diabetes and Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in weight at 12 weeks.
研究概览
简要总结
The purpose of this trial is to study the safety and efficacy of a pre-packaged, portion controlled meal plan on weight loss and glycemic control in overweight and obese patients with type 2 diabetes.
Aim 1 - Effects on Weight Assess the effects of a pre-packaged, portion controlled meal plan on weight loss in overweight and obese patients with type 2 diabetes.
The researchers hypothesize that the pre-packaged, portion controlled diet (PCD) will produce a greater weight loss than a diabetes support and education (DSE) program at 12 weeks. The study will be powered to detect between group differences of 3% of body weight. Secondarily, the researchers will assess whether there are any differences in weight during the secondary phase from weeks 13-24 when both groups will consume a PCD diet.
Aim 2 - Effects on Glycemic Control
Assess the effects of a pre-packaged, portion controlled meal plan on glycemic control in overweight and obese patients with type 2 diabetes.
The researchers hypothesize that the PCD will show greater improvement in HbA1c levels than a DSE group at 12 weeks. The study will be powered to detect between group differences of .5% in HbA1c. Secondarily, improvements and differences in HbA1c from weeks 13-24 when both groups are consuming a PCD will be assessed.
详细描述
General Design
Randomized, non-blinded, controlled clinical trial using a parallel and cross-over design of either the treatment group which receives a pre-packaged, portion-controlled (PCD) meal plan for 24 weeks (weeks 0-24) or to the control group which receives 12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24.
Study Population
Up to 120 volunteers with type 2 diabetes who are 21-75 years of age and overweight or obese (body mass index ≥ 25 and ≤ 50 kg/m2) with a fasting HbA1c level of 6.0 or greater.
Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria.
- •Type 2 diabetic men and non-pregnant or non-lactating women between the ages of 21 to 75
- •BMI ≥ 25 and ≤ 50
- •Subjects must be willing to comply with all study-related procedures
- •Participant with screening HbA1C ≥ 6.0
排除标准
- •If participants meet one of the following criteria they will be excluded.
- •Use of insulin or other pharmaceutical agent for diabetic control other than thiazolidinedione (TZD), Sulfonylurea's, or Metformin or a combination of medications.
- •BMI ≤ 24.9 or ≥ 50.1
- •Participation in another formal weight loss program within last 6 months
- •Participation in Diabetes Support and Education Program or other formal diabetes education program within last 6 months
- •Uncontrolled hypertension (systolic blood pressure > 180 or diastolic blood pressure > 100 mmHg). Participants on medication treating hypertension for at least three months are allowable.
- •Known atherosclerotic cardiovascular disease
- •History of congestive heart failure
- •History of a non-skin malignancy within the previous 5 years
- •Any major active rheumatologic, pulmonary, hepatic, renal, dermatologic disease or inflammatory condition
- •Detailed Disease and Lab Value Exclusions:
- •Active rheumatologic, dermatologic disease, or autoimmune/inflammatory condition will be defined as any patient who currently, or has a past medical history of chronic (> 2 weeks) immune modulating/suppressing medications.
- •Active pulmonary disease will be defined as any patient who has a history of, or currently requires, daily oral corticosteroids, leukotriene inhibitors, an oxygen requirement, or ventilation support for chronic disease management.
- •Active hepatic disease: defined as any patient who currently, or has a history of requiring immune modulating/suppressing medications, ammonia lowering medications, or hepatic disease related diet modifications.
- •Active renal disease: defined as any patient who currently, or has a history requiring potassium phosphate lowering medications, protein restriction diet, or hemo/peritoneal dialysis.
- •Lab value exclusions are limited to all routine electrolyte values outside the normal range, except glucose. (Sodium, potassium, chloride, bicarbonate, BUN, creatinine.)
- •History of testing HIV positive
- •History of alcohol or drug abuse
- •Weight-loss inducing medications or dietary supplements within 3 months prior to enrollment.
- •Weight loss > 5 kg during the last 6 months
- •Participation in any weight loss study or investigational drug study within 6 weeks prior to the screening
- •Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •Participants with screening triglycerides above 500 mg
- •Anyone that is physically active for ≥ 30 minutes per day as assessed in clinical interview at the screening visit
- •Uncontrolled Dyslipidemia. Participants stable on medication treating dyslipidemia for at least 3 months or more is allowable.
研究组 & 干预措施
PCD
pre-packaged, portion-controlled (PCD) meal plan for 24 weeks
干预措施: PCD (Other)
DSE
12 weeks of diabetes support and education (DSE) (weeks 0-12) and then crosses over to 12 weeks of PCD from weeks 13-24
干预措施: DSE (Other)
结局指标
主要结局
Changes in weight at 12 weeks.
时间窗: 12 weeks
次要结局
- Changes in HbA1c, lipids, inflammatory markers (hs-CRP), fasting glucose, blood pressure, waist circumference and survey measures at 12 weeks.(12 weeks)