Novel Type 2 Diabetes Mellitus Preventive Therapies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the emerging evidence that glutamine and leucine (building blocks of protein) may affect energy partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk has been further evaluated in one adult observational cohort study but data on leucine are lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce insulin resistance, a diabetes risk factor.
The primary specific aim of the research plan is to conduct a randomized, double-blind, placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history of T2DM. At the end of the grant period, we will have obtained preliminary data to plan pivotal clinical trials of glutamine coupled with or without lifestyle changes.
详细描述
Because of recruitment difficulties the design was modified several times until April 2013 when we were able to increase recruitment. The following changes were made from initial to final study design:
- Study moved from Clinical and Translational Science Institute (CTSI) to clinical setting (Nutrition and Fitness for Life Clinic)
- Ages eligible expanded from 12-19 years old to 12-19.9 years old
- Ethnicity/Race expanded from Hispanic only to include all races/ethnicities
- Patients without a past family history of T2DM were made eligible
- Study period was shortened from 6 months to 12-14 weeks
- Number of required visits were reduced from 5 visits to 3 visits (all of which took place during regularly scheduled clinic appointments)
- Open labeled but still randomized
- Those in the Glutamine arm were provided lifestyles change intervention
- Glycosylated hemoglobin (A1C) used instead of fasting Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
- Non-fasting blood draw rather than a fasting blood draw was instituted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI (k/m2) >= 95th percentile;
- •Weight 150 - 400 pounds;
- •Language: English or Spanish (The PI speaks both English and Spanish fluently).
排除标准
- •History of T2DM;
- •Prior or current drug treatmeant that would effect diabetes risk
- •Use of prescription strength glucocorticoids within three months before screening,
- •History of syndrome or medical disorder associated with significant obesity;
- •Serum creatinine >1.2 mg/dL;
- •Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >90 international units (IU)/L (= 3 X normal limits);
- •Total bilirubin >2.5 time the upper limit of normal;
- •History of moderate to extreme physical activity, past or current pregnancy;
- •9 .Use of illegal/illicit drugs;
- •Unable to comply with the protocol;
- •Any other serious disease determined by the clinician as potential study risk for the patient.
- •Have kidney or liver disorders, or conditions resulting in ammonia accumulation
- •Take Lactulose
- •Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light
- •Have manic episodes (mental illness)
- •Take medications to prevent seizures
- •Take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, ADHD medications, antilipidemiants, or thyroid hormone
- •Participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss
研究组 & 干预措施
Glutamine + Lifestyle change
Glutamine 30 grams/day X 12-14 weeks, Lifestyle change
干预措施: Glutamine (Pharmacological doses) (Drug)
Glutamine + Lifestyle change
Glutamine 30 grams/day X 12-14 weeks, Lifestyle change
干预措施: Lifestyle change (Behavioral)
No glutamine + Lifestyle change
Lifestyle change
干预措施: Lifestyle change (Behavioral)
结局指标
主要结局
Weight gain
时间窗: 12-14 weeks
次要结局
- Change in A1C(12-14 weeks)