AzTrials
AzTrials

Type2 Diabetes MellitusLIMEXNCT03155412

Adipose Tissue Expandability and Type 2 Diabetes

An observational study of Type2 Diabetes Mellitus, run by Charles University, Czech Republic at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Type2 Diabetes Mellitus
How many people
44 participants
Where
1 siteCzechia
Study dates
Jan 2016to Jan 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: 50 healthy lean men (age 30-45, BMI <26). Two groups of subjects (n=25) matched for BMI, fat mass and age.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Third Faculty of Medicine, Charles University

    Prague, 100 00

Other trials in Czechia

About this study

Official title: Limited Adipose Tissue Expandability as a Risk Factor for Development of Type 2 Diabetes: the Role of Preadipocytes

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.

Read the 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.

Keywords
Type 2 Diabetes, adipose tissue, preadipocytes, expandability, hypertrophy, hyperplasia, lipogenesis, adipogenesis, insulin sensitivity
Medical subject headings
Diabetes Mellitus, Type 2, Hypertrophy, Hyperplasia, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03155412
Study groupRoleWhat they receive
Offspring of type 2 diabetic patientsGroup 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 subjectsGroup 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adipogenic capacity of preadipocytes

    proliferation assays, messenger ribonucleic acid (mRNA) gene expression

    Measured: 3 months from the establishment of the cell culture

Secondary outcomes (3)

  1. Insulin sensitivity

    Glucose disposal measured by hyperinsulinemic-euglycemic clamp

    Measured: 3 hours investigation of the subject at the start of the study

  2. Glucose tolerance

    Oral glucose tolerance test (OGTT)

    Measured: 2 hours investigation of the subject at the start of the study

  3. Lipid metabolism

    Lipolysis, lipogenesis in cell cultures of adipocytes derived from the subjects

    Measured: 3 months from the establishment of the cell culture

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study startJan 2016
  3. Primary completionMar 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155412
Sponsor's protocol ID
16-14048S
Acronym
LIMEX
Status last verified
Feb 2020
First submitted
15 May 2017
Last updated
13 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Guilherme A, Virbasius JV, Puri V, Czech MP. Adipocyte dysfunctions linking obesity to insulin resistance and type 2 diabetes. Nat Rev Mol Cell Biol. 2008 May;9(5):367-77. doi: 10.1038/nrm2391.

    PubMed 18401346

  • Lu Q, Li M, Zou Y, Cao T. Induction of adipocyte hyperplasia in subcutaneous fat depot alleviated type 2 diabetes symptoms in obese mice. Obesity (Silver Spring). 2014 Jul;22(7):1623-31. doi: 10.1002/oby.20705. Epub 2014 Feb 11.

    PubMed 24435986

  • Alligier M, Gabert L, Meugnier E, Lambert-Porcheron S, Chanseaume E, Pilleul F, Debard C, Sauvinet V, Morio B, Vidal-Puig A, Vidal H, Laville M. Visceral fat accumulation during lipid overfeeding is related to subcutaneous adipose tissue characteristics in healthy men. J Clin Endocrinol Metab. 2013 Feb;98(2):802-10. doi: 10.1210/jc.2012-3289. Epub 2013 Jan 2.

    PubMed 23284008

  • Medina-Gomez G, Gray SL, Yetukuri L, Shimomura K, Virtue S, Campbell M, Curtis RK, Jimenez-Linan M, Blount M, Yeo GS, Lopez M, Seppanen-Laakso T, Ashcroft FM, Oresic M, Vidal-Puig A. PPAR gamma 2 prevents lipotoxicity by controlling adipose tissue expandability and peripheral lipid metabolism. PLoS Genet. 2007 Apr 27;3(4):e64. doi: 10.1371/journal.pgen.0030064.

    PubMed 17465682

  • Rossmeislova L, Malisova L, Kracmerova J, Tencerova M, Kovacova Z, Koc M, Siklova-Vitkova M, Viquerie N, Langin D, Stich V. Weight loss improves the adipogenic capacity of human preadipocytes and modulates their secretory profile. Diabetes. 2013 Jun;62(6):1990-5. doi: 10.2337/db12-0986. Epub 2013 Feb 1.

    PubMed 23378611

  • Koc M, Siklova M, Sramkova V, Stepan M, Krauzova E, Stich V, Rossmeislova L. Signs of Deregulated Gene Expression Are Present in Both CD14+ and CD14- PBMC From Non-Obese Men With Family History of T2DM. Front Endocrinol (Lausanne). 2021 Feb 15;11:582732. doi: 10.3389/fendo.2020.582732. eCollection 2020.

    PubMed 33658980

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes Mellitus, run by Charles University, Czech Republic at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adipogenic capacity of preadipocytes (time frame: 3 months from the establishment of the cell culture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155412, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in