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Completed

NCT Number: NCT02881697

mTOR and Adipose Tissue Inflammation

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

adipose tissue sampling

Other

Primary outcomes

  1. mTORC2 activity in adipose tissue measured by immunoblot

    Time frame: single time point at surgery

    measurement of mTORC2 activity in adipose tissue once at surgery

Secondary outcomes

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

    Time frame: single time point at surgery

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

Other outcomes

  1. Insulin resistance measured with fasting plasma insulin and fasting glucose

    Time frame: single time point at surgery

    measurement of fasting plasma insulin and fasting Glucose once at surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

mTOR and Adipose Tissue Inflammation in Humans

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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