ObesityNCT02881697
mTOR and Adipose Tissue Inflammation
An observational study of Obesity, run by University Hospital, Basel, Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Adipose tissue sampling
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2016to 27 Jul 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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)
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- Substance abuse, alcohol abuse
- Inability to follow procedures due to psychological disorders, dementia
- insufficient knowledge of project language (German)
About this study
Official title: mTOR and Adipose Tissue Inflammation in Humans
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.
- Conditions
- Obesity
- Being tested
- Adipose tissue sampling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue samplingOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Adipose tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
mTORC2 activity in adipose tissue measured by immunoblot
measurement of mTORC2 activity in adipose tissue once at surgery
Measured: single time point at surgery
Secondary outcomes (1)
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
Measured: single time point at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start27 Sep 2016
- Primary completion23 Apr 2019
- Study completion27 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Study chair, St. Claraspital klinische Forschungsabteilung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881697
- Sponsor's protocol ID
- mTOR
- Status last verified
- Aug 2019
- First submitted
- 18 Aug 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mTOR and Adipose Tissue Inflammation in Humans
- ClinicalTrials.gov ID
- NCT02881697
- Acronym / sponsor ID
- mTOR
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 27 Jul 2019 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese insulin-resistant subjects | – | Other: Adipose tissue samplingAdipose tissue sampling in obese volunteers (BMI > 35kg/m2) aged 18- max. 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery |
| Lean insulin-sensitive controls | – | Other: Adipose tissue samplingAdipose tissue sampling in normal weight patients (BMI < 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery |
| Obese diabetic subjects | – | Other: Adipose tissue samplingAdipose tissue sampling in obese volunteers (BMI > 35kg/m2) aged 18- max. 60 years, males and females; diabetic, scheduled for elective bariatric surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- Known diabetes mellitus
- Chronic inflammatory disease (inflammatory bowel disease, rheumatoid disease, cancer)
- Acute inflammatory disease
- Known renal disease: kidney failure
- Pregnancy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipose tissue sampling | Other | Lean insulin-sensitive controls, Obese diabetic subjects, Obese insulin-resistant subjects |
Primary outcome
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
1 secondary outcome
Mcp1 messenger ribonucleic acid (mRNA) level in adipose tissue measured by quantitative polymerase chain reaction (PCR)
Time frame: single time point at surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, MD study chair
St. Claraspital klinische Forschungsabteilung
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Basel, Switzerland.
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 2 inclusion and 9 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 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
mTORC2 activity in adipose tissue measured by immunoblot (time frame: single time point at surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2019.