NCT00964184已完成4 期
Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group of the study population.
详细描述
A phase IV on T2DM with BMI < 25 kg/m2 and age 14-40 years.
Primary Objectives:
- To investigate phenotype (body composition, anthropometry, pancreatic imaging and endocrine function, insulin resistance, autoantibodies, and other biochemical variables) and genetic (known mutations and polymorphisms) correlates in young (age 14-40 years) diabetic patients (non-type 1).
Secondary Objectives:
- To study anthropometric and body fat distribution including truncal fat, subcutaneous and intra-abdominal fat in non-obese young patients with diabetes (non-type 1).
- To study whether insulin secretion, insulin resistance or a combination of both is/are the predominant defect(s) in non-obese young diabetics (non-type 1).
- To study the prevalence of autoimmunity and/or specific genetic abnormalities in this subgroup of diabetics.
- To estimate approximate prevalence of diagnostic subcategories based on the sample of population, and profile of complications in each category.
- To propose rational use of specialized investigations (e.g. GAD65, HNF-1α mutations etc) while investigating a newly diagnosed young diabetic.
- To determine the rational therapeutic option and prognosis in this sub-population of diabetics based on anthropometric, biochemical, and etiological profiles.
- Sample size: 205 patients to be enrolled and 120 patients to be enrolled for sub group study
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
- 14 Years 至 40 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having BMI <25 kg/m
- •Drug naïve patients
- •Patients on mono-therapy with metformin (< 1g/day).
排除标准
- •Type 1 diabetes
- •Type 2 Diabetes on any other oral hypoglycemic agent other than metformin
- •Pregnancy or lactation
- •Insulin or Sulfonylurea treatment within the past 3 months
- •Has received any investigational drug with the past 60 days
- •History of prior allergy or hypersensitivity to any drug (unless approved by investigator)
- •HbA1c < 7.5% or > 8.5%.
- •Unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin.
- •Any patient on insulin.
- •Females of child bearing potential who are not using adequate contraception during the study period.
- •Insulin dependent or history of ketoacidosis requiring hospitalization
- •Acute infections
- •Advanced end-organ damage (CLD, CRF etc.)
- •Diabetes with clinically significant or advanced end-organ damage
研究组 & 干预措施
Drug
Experimental
1 gm metformin per day
干预措施: Metformin (Drug)
control
Other
lifestyle intervention
干预措施: Lifestyle modification (Behavioral)
结局指标
主要结局
HbA1c
时间窗: 18 weeks
HbA1C
时间窗: 12 weeks
次要结局
- insulin(12 weeks)
- Assessment of safety profile of sitagliptin(18 weeks)
研究者
Dr Anoop Misra
Director, Diabetes, Obesity and Metabolic Disorders
Diabetes Foundation, India
研究点 (1)
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