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mTOR and Adipose Tissue Inflammation

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT02881697
Collaborator
(none)
80
Enrollment
33.9
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine protein kinase that controls growth and metabolism. In mammals (including humans), mammalian TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene. In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic insulin resistance, investigators have already performed transcriptomics and proteomics analysis on visceral white adipose tissue in a mouse model. The aim of the study is to confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.

Condition or Disease Intervention/Treatment Phase
  • Other: Adipose tissue sampling

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
mTOR and Adipose Tissue Inflammation in Humans
Actual Study Start Date :
Sep 27, 2016
Actual Primary Completion Date :
Apr 23, 2019
Actual Study Completion Date :
Jul 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Obese insulin-resistant subjects

Adipose tissue sampling in obese volunteers (BMI > 35kg/m2) aged 18- max. 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery

Other: Adipose tissue sampling
Lean insulin-sensitive controls

Adipose tissue sampling in normal weight patients (BMI < 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery

Other: Adipose tissue sampling
Obese diabetic subjects

Adipose tissue sampling in obese volunteers (BMI > 35kg/m2) aged 18- max. 60 years, males and females; diabetic, scheduled for elective bariatric surgery

Other: Adipose tissue sampling

Outcome Measures

Primary Outcome Measures

  1. mTORC2 activity in adipose tissue measured by immunoblot [single time point at surgery]

    measurement of mTORC2 activity in adipose tissue once at surgery

Secondary Outcome Measures

  1. Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue measured by quantitative polymerase chain reaction (PCR) [single time point at surgery]

    measurement of Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue once at surgery

Other Outcome Measures

  1. Insulin resistance measured with fasting plasma insulin and fasting glucose [single time point at surgery]

    measurement of fasting plasma insulin and fasting Glucose once at surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Obese volunteers (BMI > 35kg/m2) aged 18 to a maximum of 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery.

  • Normal weight patients (BMI < 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery.

Exclusion Criteria:

  • Known diabetes mellitus

  • Chronic inflammatory disease (inflammatory bowel disease, rheumatoid disease, cancer)

  • Acute inflammatory disease

  • Known renal disease: kidney failure

  • Pregnancy:

  • history of gastrointestinal surgery with major changes to the gastrointestinal tract (removal of stomach, any GI-bypass)

  • Substance abuse, alcohol abuse

  • Inability to follow procedures due to psychological disorders, dementia

  • insufficient knowledge of project language (German)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Christoph Beglinger, MD, St. Claraspital klinische Forschungsabteilung

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02881697
Other Study ID Numbers:
  • mTOR
First Posted:
Aug 29, 2016
Last Update Posted:
Aug 14, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Inflammation

Study Results

No Results Posted as of Aug 14, 2019