Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
98 participants
OBSERVATIONAL
2012-04-25
2022-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Obese with type 2 diabetes
Bariatric surgery
Sleeve gastrectomy
Blood sampling
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 pressure
Systolic and diastolic blood pressure will be measured.
Anthropometric measurements
Body weight, height and waist circumference will be measured.
Body composition
Body composition will be evaluated by dual-energy X-ray absorptiometry.
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry.
Food intake
Food intake, energy intake and food quality will be evaluated using the food frequence questionnaire.
Adipose tissue biopsy
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.
Obese insulin-sensitive
Bariatric surgery
Sleeve gastrectomy
Blood sampling
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 pressure
Systolic and diastolic blood pressure will be measured.
Anthropometric measurements
Body weight, height and waist circumference will be measured.
Body composition
Body composition will be evaluated by dual-energy X-ray absorptiometry.
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry.
Food intake
Food intake, energy intake and food quality will be evaluated using the food frequence questionnaire.
Adipose tissue biopsy
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.
Obese insulin-resistant
Bariatric surgery
Sleeve gastrectomy
Blood sampling
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 pressure
Systolic and diastolic blood pressure will be measured.
Anthropometric measurements
Body weight, height and waist circumference will be measured.
Body composition
Body composition will be evaluated by dual-energy X-ray absorptiometry.
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry.
Food intake
Food intake, energy intake and food quality will be evaluated using the food frequence questionnaire.
Adipose tissue biopsy
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bariatric surgery
Sleeve gastrectomy
Blood sampling
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 pressure
Systolic and diastolic blood pressure will be measured.
Anthropometric measurements
Body weight, height and waist circumference will be measured.
Body composition
Body composition will be evaluated by dual-energy X-ray absorptiometry.
Resting metabolic rate
Resting metabolic rate will be measured by indirect calorimetry.
Food intake
Food intake, energy intake and food quality will be evaluated using the food frequence questionnaire.
Adipose tissue biopsy
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. BMI ≥ 35 kg/m2 without cardiometabolic complications or ≥ 30 kg/m2 if presence of type 2 diabetes or hypertension
3. ≥ 18 years old
4. Non smoker
5. Sedentary (less than 3 hours of regular physical activity per week)
Exclusion Criteria
2. 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)
3. Infection in the last month (fever, antibiotics treatment)
4. Cancer in the last 3 years
5. Chronic inflammatory disease
6. 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)
7. Uncontrolled disease of pituitary or thyroid gland
8. Bleeding disorders
9. Alcohol or drug abuses
10. Claustrophobia
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institut de Recherches Cliniques de Montreal
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rémi Rabasa-Lhoret
Full professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rémi Rabasa-Lhoret
Role: PRINCIPAL_INVESTIGATOR
Institut de recherches cliniques de Montréal
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-22
Identifier Type: -
Identifier Source: org_study_id