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Adipose Tissue Expandability and Type 2 Diabetes (LIMEX)

C

Charles University, Czech Republic

Status

Completed

Conditions

Type2 Diabetes Mellitus

Study type

Observational

Funder types

Other

Identifiers

NCT03155412
16-14048S

Details and patient eligibility

About

The goal of the study is to analyze deviations in adipogenic potential and metabolic properties of preadipocytes in subjects with genetic predisposition to type 2 diabetes, and thus identify factors that underlie hypertrophic growth of adipose tissue associated with the development of this disease.

Full description

Adipose tissue (AT) expands in response to excessive energy intake by hyperplasia or hypertrophy. While hyperplasia is associated with preservation of insulin sensitivity, hypertrophic AT exerts a number of metabolic defects. The mechanisms by which hyperplasia is suppressed at the expense of AT hypertrophy remain unknown, but it is expected that the hypertrophy of adipocytes is primarily driven by insufficient recruitment and differentiation of available preadipocytes. The limitation of hyperplasia occurs already in non-obese healthy subjects who are genetically predisposed to Type 2 Diabetes. Using these and control subjects, the LIMEX project aims to analyze the mechanisms of AT expandability. The project will combine in vivo characterization of AT and in vitro studies on human preadipocytes derived from AT biopsies obtained during clinical study. In vitro, proliferation, adipogenesis and lipogenesis of adipose cells will be monitored and these properties will be related to the degree of AT hypertrophy in vivo, insulin sensitivity and genetic predisposition to metabolic complications.

Enrollment

44 patients

Sex

Male

Ages

30 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy non-obese men
  • subject has genetic predisposition for T2DM- i.e. two first-degree relatives (parents, siblings) or one first-degree relative and two second-degree relatives with type 2 diabetes (grandparents, uncle, aunt) diagnosed with T2DM OR
  • subject without any family history of T2DM.

Exclusion criteria

  • any prior history of obesity
  • elevated triglyceride concentration (above 1.7 mmol/l)
  • hypertension
  • thyroid or other endocrine disease
  • smoking
  • drug abuse

Trial design

44 participants in 2 patient groups

Offspring of type 2 diabetic patients
Description:
Group 1: 25 healthy lean men (age 30-45, BMI \<28) with genetic predisposition for type 2 diabetes mellitus (T2DM) - i.e. their two first-degree relatives (parents, siblings) or one first-degree relative and two second-degree relatives with type 2 diabetes (grandparents, uncle, aunt) were diagnosed with T2DM. Exclusion criteria: any prior history of obesity, elevated triglyceride concentration, hypertension, thyroid or other endocrine disease, smoking, drug abuse.
Control subjects
Description:
Group 2: 25 healthy lean men (age 30-45, BMI \<28) without any family history of T2DM. Exclusion criteria: any prior history of obesity, elevated triglyceride concentration, hypertension, thyroid or other endocrine disease, smoking, drug abuse. Subjects matched for BMI, fat mass and age to subjects in Group 1 will be recruited.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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