ObesityETAPPNCT05304325
Adipose Tissue Pre and Post Bariatric Surgery
An observational study of Obesity, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
Published data suggest that inflammation and fibrosis of adipose tissue could be factors favoring the development of insulin resistance in obese individuals and that a decrease in the activity of the AMP-activity kinase protein (AMPK) could lead to these dysfunctions. However, very few data are available in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric surgery, Blood sampling and Blood pressure
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2012to 30 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of obese individuals with type 2 diabetes, insulin-sensitive obese individuals and insulin-resistant obese individuals, all awaiting bariatric surgery.
Who may be able to join
- Awaiting bariatric surgery
- BMI ≥ 35 kg/m2 without cardiometabolic complications or ≥ 30 kg/m2 if presence of type 2 diabetes or hypertension
- ≥ 18 years old
- Non smoker
- Sedentary (less than 3 hours of regular physical activity per week)
Who cannot join
- Type 1 diabetes
- Acute event in the last 3 months (myocardial infarction, cerebrovascular hemorrhage or transient cerebral ischemia, unstable angina, peripheral vascular disease, revascularization or angioplasty, recent hospitalization for more than 4 days)
- Infection in the last month (fever, antibiotics treatment)
- Cancer in the last 3 years
- Chronic inflammatory disease
- Pharmacologic treatment (any medication affecting glucose metabolism (except those for diabetes), hypotensive medication unless stable dose for at least 1 month, lipid-lowering medication unless stable dose for at least 1 month)
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- Uncontrolled disease of pituitary or thyroid gland
- Bleeding disorders
- Alcohol or drug abuses
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
Official title: Evaluation of Adipose Tissue Pre and Post Bariatric Surgery
Published data suggest that inflammation and fibrosis of adipose tissue could be factors favoring the development of insulin resistance in obese individuals and that a decrease in the activity of the AMP-activity kinase protein (AMPK) could lead to these dysfunctions. However, very few data are available in humans.
There is also growing interest in persistent organic pollutants (POPs) as a cardiometabolic and type 2 diabetes (T2D) risk factor. There is some evidence to suggest that POPs directly contribute to lipid metabolism dysfunction and insulin resistance. Additionally, POPs are stocked in adipose tissue. The accumulation of POPs in adipose tissue therefore limits their bioavailability to other organs, thus reducing their systemic toxicity. It has been observed that a large amplitude weight loss leads to a significant increase in POPs in the blood.
Read more
The goal of this project is to identify adipose tissue factors/dysfunctions that contribute to insulin resistance and type 2 diabetes associated with obesity in humans and thus raise avenues for screening and treatment of these metabolic complications. More specifically, the objectives are:
- To study the relationship between AMPK, fibrosis and inflammation of adipose tissue and their role in the development of insulin resistance and T2D associated with obesity;
- To examine the relationship between POPs and the cardiometabolic profile.
- Conditions
- Obesity
- Being tested
- Bariatric surgery, Blood sampling, Blood pressure, Anthropometric measurements, Body composition
- Keywords
- Bariatric surgery, Persistant organic pollutants, Type 2 diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Sleeve gastrectomy
Blood samplingOther
Blood samples will be collected to measure glucose, insulin, albumin, uric acid, HbA1c, lipids, hepatic enzymes, TSH, hs-CRP, complete blood cell counts and persistant organic pollutants
Blood pressureOther
Systolic and diastolic blood pressure will be measured.
Anthropometric measurementsOther
Body weight, height and waist circumference will be measured.
Body compositionOther
Body composition will be evaluated by dual-energy X-ray absorptiometry.
Resting metabolic rateOther
Resting metabolic rate will be measured by indirect calorimetry.
Food intakeOther
Food intake, energy intake and food quality will be evaluated using the food frequence questionnaire.
Adipose tissue biopsyProcedure or surgery
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.
| Study group | Role | What they receive |
|---|---|---|
| Obese with type 2 diabetes | Not described Receives: Procedure: Bariatric surgery; Other: Blood sampling; Other: Blood pressure; Other: Anthropometric measurements; Other: Body composition; Other: Resting metabolic rate; Other: Food intake; Procedure: Adipose tissue biopsy | |
| Obese insulin-sensitive | Not described Receives: Procedure: Bariatric surgery; Other: Blood sampling; Other: Blood pressure; Other: Anthropometric measurements; Other: Body composition; Other: Resting metabolic rate; Other: Food intake; Procedure: Adipose tissue biopsy | |
| Obese insulin-resistant | Not described Receives: Procedure: Bariatric surgery; Other: Blood sampling; Other: Blood pressure; Other: Anthropometric measurements; Other: Body composition; Other: Resting metabolic rate; Other: Food intake; Procedure: Adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
Measured: Before bariatric surgery
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
Measured: 6 months after bariatric surgery
Secondary outcomes (15)
Calory intake
Measured: Before bariatric surgery
Calory intake
Measured: 3 months after bariatric surgery
Calory intake
Measured: 6 months after bariatric surgery
Food quality using the Food Frequency Questionnaire
Measured: Before bariatric surgery
Food quality using the Food Frequency Questionnaire
Measured: 3 months after bariatric surgery
Food quality using the Food Frequency Questionnaire
Measured: 6 months after bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Measured: Before bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Measured: 3 months after bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Measured: 6 months after bariatric surgery
AMP-activated protein kinase
Measured: Before bariatric surgery
AMP-activated protein kinase
Measured: 3 months after bariatric surgery
AMP-activated protein kinase
Measured: 6 months after bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Measured: Before bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Measured: 3 months after bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Measured: 6 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start25 Apr 2012
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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.
- 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304325
- Sponsor's protocol ID
- 2011-22
- Acronym
- ETAPP
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adipose Tissue Pre and Post Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05304325
- Acronym / sponsor ID
- ETAPP / 2011-22
- Conditions
- Obesity
- Keywords
- Bariatric surgery, Persistant organic pollutants, Type 2 diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 25 Apr 2012 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 31 Mar 2022 (actual)
- 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.
Published data suggest that inflammation and fibrosis of adipose tissue could be factors favoring the development of insulin resistance in obese individuals and that a decrease in the activity of the AMP-activity kinase protein (AMPK) could lead to these dysfunctions. However, very few data are available in humans.
There is also growing interest in persistent organic pollutants (POPs) as a cardiometabolic and type 2 diabetes (T2D) risk factor. There is some evidence to suggest that POPs directly contribute to lipid metabolism dysfunction and insulin resistance. Additionally, POPs are stocked in adipose tissue. The accumulation of POPs in adipose tissue therefore limits their bioavailability to other organs, thus reducing their systemic toxicity. It has been observed that a large amplitude weight loss leads to a significant increase in POPs in the blood.
The goal of this project is to identify adipose tissue factors/dysfunctions that contribute to insulin resistance and type 2 diabetes associated with obesity in humans and thus raise avenues for screening and treatment of these metabolic complications. More specifically, the objectives are:
- To study the relationship between AMPK, fibrosis and inflammation of adipose tissue and their role in the development of insulin resistance and T2D associated with obesity;
- To examine the relationship between POPs and the cardiometabolic profile.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese with type 2 diabetes | – | Procedure: Bariatric surgery, Other: Blood sampling, Other: Blood pressure, Other: Anthropometric measurements, Other: Body composition, Other: Resting metabolic rate, Other: Food intake, Procedure: Adipose tissue biopsy |
| Obese insulin-sensitive | – | Procedure: Bariatric surgery, Other: Blood sampling, Other: Blood pressure, Other: Anthropometric measurements, Other: Body composition, Other: Resting metabolic rate, Other: Food intake, Procedure: Adipose tissue biopsy |
| Obese insulin-resistant | – | Procedure: Bariatric surgery, Other: Blood sampling, Other: Blood pressure, Other: Anthropometric measurements, Other: Body composition, Other: Resting metabolic rate, Other: Food intake, Procedure: Adipose tissue biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of obese individuals with type 2 diabetes, insulin-sensitive obese individuals and insulin-resistant obese individuals, all awaiting bariatric surgery.
Key inclusion criteria (5 listed)
- Awaiting bariatric surgery
- BMI ≥ 35 kg/m2 without cardiometabolic complications or ≥ 30 kg/m2 if presence of type 2 diabetes or hypertension
- ≥ 18 years old
- Non smoker
- Sedentary (less than 3 hours of regular physical activity per week)
Key exclusion criteria (10 listed)
- Type 1 diabetes
- Acute event in the last 3 months (myocardial infarction, cerebrovascular hemorrhage or transient cerebral ischemia, unstable angina, peripheral vascular disease, revascularization or angioplasty, recent hospitalization for more than 4 days)
- Infection in the last month (fever, antibiotics treatment)
- Cancer in the last 3 years
- Chronic inflammatory disease
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 |
|---|---|---|
| Bariatric surgerySleeve gastrectomy | Procedure or surgery | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Blood samplingBlood samples will be collected to measure glucose, insulin, albumin, uric acid, HbA1c, lipids, hepatic enzymes, TSH, hs-CRP, complete blood cell counts and persistant organic pollutants | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Blood pressureSystolic and diastolic blood pressure will be measured. | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Anthropometric measurementsBody weight, height and waist circumference will be measured. | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Body compositionBody composition will be evaluated by dual-energy X-ray absorptiometry. | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Resting metabolic rateResting metabolic rate will be measured by indirect calorimetry. | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Food intakeFood intake, energy intake and food quality will be evaluated using the food frequence questionnaire. | Other | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
| Adipose tissue biopsyA sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region. | Procedure or surgery | Obese insulin-resistant, Obese insulin-sensitive, Obese with type 2 diabetes |
Primary outcome
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
Time frame: Before bariatric surgery
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
Time frame: 6 months after bariatric surgery
15 secondary outcomes
Calory intake
Time frame: Before bariatric surgery
Calory intake
Time frame: 3 months after bariatric surgery
Calory intake
Time frame: 6 months after bariatric surgery
Food quality using the Food Frequency Questionnaire
Time frame: Before bariatric surgery
Food quality using the Food Frequency Questionnaire
Time frame: 3 months after bariatric surgery
Food quality using the Food Frequency Questionnaire
Time frame: 6 months after bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Time frame: Before bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Time frame: 3 months after bariatric surgery
Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry
Time frame: 6 months after bariatric surgery
AMP-activated protein kinase
Time frame: Before bariatric surgery
AMP-activated protein kinase
Time frame: 3 months after bariatric surgery
AMP-activated protein kinase
Time frame: 6 months after bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Time frame: Before bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Time frame: 3 months after bariatric surgery
Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry
Time frame: 6 months after bariatric surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry (time frame: Before bariatric surgery). The study lists 2 primary outcomes in all. 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 31 Mar 2022.