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临床试验/CTRI/2022/02/040316
CTRI/2022/02/040316已完成不适用

Comparison of Beta cell dysfunction and Insulin resistance among recently detected type 2 Diabetic patients of different BMI categories using HOMA2 model.

Dr Sarin S M1 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2022年2月21日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
850
试验地点
1
主要终点
1)Body mass index

研究概览

简要总结

Introduction: Obesity and insulin resistance is the cornerstone of pathogenesis in type 2 Diabetes Mellitu patients. Many studies have identified a large section of patients who are not adhering to this expected body habitus and has normal or even lean body weight with associated type 2 diabetes. It has been proposed that such patients might be having increased level of insulin secretory defect early in disease progression compared to overweight phenotype. This study intends to find out the relative beta cell dysfunction and insulin resistance in lean, normal body weight and overweight body types among recently detected type 2 diabetic patients using HOMA2 model.

Methodology: Crossectional observational study in which recently detected (<5yrs duration) type 2 diabetic patients diagnosed based on ADA 2010 criteria in the age group >30 years is selected from NCD clinic of FHCs in Kannur district, Kerala. Patients will be recruited by cluster sampling technique and data collected from them using prevalidated questionnaire after informed consent. Patients are categorised into lean, normal body weight and overweight patients based on BMI. From each of these groups 35 patients [sample size calculation n = (Zα/2+Zβ)2 *2*σ2 / d2] are randomly selected and their coupled fasting blood sugar, fasting insulin level estimated. Using these values respective insulin resistance(HOMA-IR) and beta cell function(HOMA-%B) will be calculated by the updated Homeostatic Model Assessment (HOMA2).

Analysis: The descriptive data will be represented using frequency, percentage, mean and standard deviation. Three subgroups namely lean body weight, normal body weight and overweight will be compared for their relative beta cell secretory defect and insulin resistance using ANOVA.

研究设计

研究类型
Observational

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Recent detected (<5yrs duration) Type 2 Diabetic patients diagnosed based on ADA 2010 criteria in the age group >30 years in Kannur District, Kerala.

排除标准

  • Patients having Chronic Kidney Disease with GFR<60ml/min/1.73m2 2)Patients diagnosed with Chronic liver disease, chronic Infections and Malignancy.
  • Patients who are using insulin for treatment.

结局指标

主要结局

1)Body mass index

时间窗: 1)Body mass index - baseline | 2)Beta cell dysfunction(calculated as HOMA-%B) and insulin resistance (calculated as HOMA-IR) - baseline

2)Beta cell dysfunction(calculated as HOMA-%B) and insulin resistance (calculated as HOMA-IR)

时间窗: 1)Body mass index - baseline | 2)Beta cell dysfunction(calculated as HOMA-%B) and insulin resistance (calculated as HOMA-IR) - baseline

次要结局

  • Waist circumference(Waist Hip ratio)

研究者

发起方
Dr Sarin S M
申办方类型
Other [self]

研究点 (1)

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