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临床试验/NCT02017210
NCT02017210已完成不适用

Insulin-sensitive Obesity: Prospective and Interventional Studies

Garvan Institute of Medical Research1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Insulin Sensitivity

研究概览

简要总结

People who are overweight and/or obese are at risk of insulin resistance and type 2 diabetes. However, research has shown that some overweight and/or obese individuals remain insulin-sensitive and metabolically healthy despite their unhealthy body weight.

The investigators hypothesise that overweight and/or obese people who were deemed insulin-sensitive in previous studies will maintain their insulin sensitivity and metabolic health over time. The investigators also hypothesise that the preservation of insulin sensitivity will be accompanied by key metabolic health markers.

详细描述

While obesity is a risk factor for metabolic disease, sub cohorts with obesity not complicated by the metabolic syndrome have been described. These so called "metabolically healthy obese" may have reduced risk of type 2 diabetes, cardiovascular disease and all-cause mortality compared with individuals with obesity who present with components of the metabolic syndrome.

Longitudinal studies with diabetes and cardiovascular disease risk endpoints reported that individuals with obesity who are metabolically healthy (MHO) held an intermediate health status, such that they were still worse off than the healthy normal-weight individuals. While there have been studies evaluating the stability of the MHO phenotype over time, no study has reported the durability of insulin-sensitivity per se, as measured by the gold-standard hyperinsulinaemic-euglycaemic clamp. In the present study, we aimed to trace the change in insulin resistance/sensitivity, and to uncover predictors of insulin resistance in older age. The secondary aims were to trace the change in body composition, fat distribution and metabolic markers over time in a well-phenotyped cohort studied approximately 5-6 years apart.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
26 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participation in two previous studies conducted at the Garvan Institute of Medical Research Clinical Research Facility (described in the other publications 1-3).
  • Willingness to give written informed consent and willingness to participate in the study.

排除标准

  • Pregnant and/or lactating women.

结局指标

主要结局

Insulin Sensitivity

时间窗: 6 years

The change in insulin sensitivity (as measured by M-value normalised to insulin from hyperinsulinemic-euglycemic clamp) was determined "Follow-up Value - Baseline Value" /"Time between measurements". There were 2 time points 6 years apart

次要结局

  • Body Mass Index(6 years)
  • Visceral Fat Volume(6 years)
  • Diastolic Blood Pressure(6 years)
  • Waist Circumference(6 years)
  • Body Fat Mass(6 years)
  • Fasting Blood Glucose(6 years)
  • Body FFM(6 years)
  • Systolic Blood Pressure(6 years)
  • Fasting Serum Insulin(6 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorit Samocha-Bonet

Group leader Clinical Insulin Resistance Group

Garvan Institute of Medical Research

研究点 (1)

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