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Adipose Tissue Expandability and Type 2 Diabetes (LIMEX)

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ClinicalTrials.gov Identifier: NCT03155412
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Type2 Diabetes Mellitus

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Limited Adipose Tissue Expandability as a Risk Factor for Development of Type 2 Diabetes: the Role of Preadipocytes
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Offspring of type 2 diabetic patients
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
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.


Outcome Measures

Primary Outcome Measures :
  1. Adipogenic capacity of preadipocytes [ Time Frame: 3 months from the establishment of the cell culture ]
    proliferation assays, messenger ribonucleic acid (mRNA) gene expression


Secondary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 3 hours investigation of the subject at the start of the study ]
    Glucose disposal measured by hyperinsulinemic-euglycemic clamp

  2. Glucose tolerance [ Time Frame: 2 hours investigation of the subject at the start of the study ]
    Oral glucose tolerance test (OGTT)

  3. Lipid metabolism [ Time Frame: 3 months from the establishment of the cell culture ]
    Lipolysis, lipogenesis in cell cultures of adipocytes derived from the subjects


Biospecimen Retention:   Samples With DNA
adipose tissue plasma / serum preadipocytes (cells)

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
50 healthy lean men (age 30-45, BMI <26). Two groups of subjects (n=25) matched for BMI, fat mass and age.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155412


Contacts
Contact: Michaela Siklova, PhD +420 604 254 992 michaela.siklova@lf3.cuni.cz
Contact: Lenka Rossmeislova, PhD +420 267 102 211 lenka.rossmeislova@lf3.cuni.cz

Locations
Czechia
Third Faculty of Medicine, Charles University Recruiting
Prague, Czechia, 100 00
Contact: Michaela Siklova, PhD    +420 267 102 211    michaela.siklova@lf3.cuni.cz   
Principal Investigator: Vladimir Stich, prof         
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Vladimir Stich, prof Third faculty of medicine, Charles University in Prague
More Information

Publications:
Responsible Party: Vladimir Stich, Professor, MUDr, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT03155412     History of Changes
Other Study ID Numbers: 16-14048S
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vladimir Stich, Charles University, Czech Republic:
Type 2 Diabetes
adipose tissue
preadipocytes
expandability
hypertrophy
hyperplasia
lipogenesis
adipogenesis
insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases