Correlation of leptin with insulin resistance in normal, overweight and obese Type 2 diabetic patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Strength and direction of correlation between serum leptin concentration and HOMA-IR at baseline in adults with Type 2 diabetes mellitus
研究概览
简要总结
This is a prospective cross-sectional observational study to be conducted at Kasturba Hospital Manipal from October 2025 to December 2026. The study aims to evaluate the correlation of serum leptin with insulin resistance in adults with type 2 diabetes mellitus (T2DM) across different BMI categories (normal, overweight, obese). A total of 98 participants aged eighteen to sixty five year old with Type 2 diabetics on stable treatment will be enrolled. Clinical anthropometric and biochemical parameters including fasting glucose, HbA1c ,lipid profile, fasting insulin and serum leptin with ELISA will be assessed. Insulin resistance will be calculated using HOMA IR.
The primary outcome is to study the clinical and biochemical correlation of leptin with insulin resistance in Type 2 diabetes mellitus using anthropometric and biochemical parameters. Data will be analyzed using ANOVA/Kruskal Wallis correlation and regression method. Findings my help establish leptin as a biomarker of insulin resistance and guide personalized management of Type 2 diabetes mellitus.
The study will be conducted after approval from ethics committee
Date of first enrolment: 15/10/2015
Estimated trial duration: 14-15 months
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ADULTS AGED 18-65 YEARS OF AGE DIAGNOSED WITH TYPE 2DM PATIENTS ON A REGULAR TREATMENT REGIMEN FOR ATLEAST 3 MONTHS (ADMITTED IN KASTURBA HOSPITAL, MANIPAL UNIVERSITY, MAHE.
- •MADHA NAGAR, UDUPI KARNATAKA 576104).
排除标准
- •INDIVIDUALS WITH TYPE 1 DIABETES CUSHING SYNDROME OR ADRENAL DISORDER PATIENTS WITH CHRONIC INFLAMMATORY DISEASE SUCH AS RHEUMATOID ARTHRITIS INFLAMMATORY BOWEL DISEASE SLE PATIENTS PRESENTING WITH SEPSIS UTI CELLULITIS PATIENT WITH RECURRENT INFECTIONS PREGNANT OR LACTATING WOMEN PATIENTS ON OCPs PATIENTS ON STEROIDS HORMONE REPLACEMENT THERAPY PATIENTS ON INSULIN SECRETAGOUGES AND INSULIN PATIENTS ON ANTI THYROID DRUGS PATIENTS ON ANTI-OBESITY DRUGS (ADMITTED IN KASTURBA HOSPITAL, MANIPAL UNIVERSITY, MAHE.
- •MADHA NAGAR, UDUPI KARNATAKA 576104).
结局指标
主要结局
Strength and direction of correlation between serum leptin concentration and HOMA-IR at baseline in adults with Type 2 diabetes mellitus
时间窗: Baseline (single timepoint at enrolment)
次要结局
- Comparison of serum leptin and insulin resistance across BMI groups(baseline)
- Effect modification of BMI on leptin-insulin resistance relationship(Baseline)
- Metabolic profile differences in Type2DM across BMI groups(baseline)
研究者
Gayatri Suneja
KMC Manipal