NCT02881697

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

September 27, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

August 18, 2016

Last Update Submit

August 12, 2019

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • mTORC2 activity in adipose tissue measured by immunoblot

    measurement of mTORC2 activity in adipose tissue once at surgery

    single time point at surgery

Secondary Outcomes (1)

  • Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue measured by quantitative polymerase chain reaction (PCR)

    single time point at surgery

Other Outcomes (1)

  • Insulin resistance measured with fasting plasma insulin and fasting glucose

    single time point at surgery

Study Arms (3)

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

Interventions

Adipose tissue samplingOTHER
Lean insulin-sensitive controlsObese diabetic subjectsObese insulin-resistant subjects

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese patients (BMI \>35 kg/m2) with insulin resistance and lean controls (BMI \< 27kg/m2) scheduled for elective surgery for non-inflammatory conditions such as gallstone disease, diverticular disease or - in the case of obese subjects - bariatric surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Adipose tissue

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Beglinger, MD

    St. Claraspital klinische Forschungsabteilung

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 29, 2016

Study Start

September 27, 2016

Primary Completion

April 23, 2019

Study Completion

July 27, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08