mTOR and Adipose Tissue Inflammation

Obesity Clinical Trial

Official title:

mTOR and Adipose Tissue Inflammation in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881697
• Other study ID #: mTOR
• Status: Completed
• Start date: September 27, 2016
• Est. completion date: July 27, 2019

Study information

• Verified date: August 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 27, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammation
• Obesity

Intervention

Other:
• Adipose tissue sampling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Insulin resistance measured with fasting plasma insulin and fasting glucose	measurement of fasting plasma insulin and fasting Glucose once at surgery	single time point at surgery
Primary	mTORC2 activity in adipose tissue measured by immunoblot	measurement of mTORC2 activity in adipose tissue once at surgery	single time point at surgery
Secondary	Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue measured by quantitative polymerase chain reaction (PCR)	measurement of Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue once at surgery	single time point at surgery