Adipose Tissue Pre and Post Bariatric Surgery

Obesity Clinical Trial

— ETAPP  

Official title:

Evaluation of Adipose Tissue Pre and Post Bariatric Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05304325
• Other study ID #: 2011-22
• Status: Active, not recruiting
• Start date: April 25, 2012
• Est. completion date: September 30, 2022

Study information

• Verified date: March 2022
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: September 30, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Awaiting bariatric surgery

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:

1. Type 1 diabetes

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Bariatric surgery
Sleeve gastrectomy

Other:
• 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.

Procedure:
• Adipose tissue biopsy
A sample of 3-5g of adipose tissue will be collected under local anesthesia by needle aspiration in the periumbilical region.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry		Before bariatric surgery
Primary	Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry		6 months after bariatric surgery
Secondary	Calory intake		Before bariatric surgery
Secondary	Calory intake		3 months after bariatric surgery
Secondary	Calory intake		6 months after bariatric surgery
Secondary	Food quality using the Food Frequency Questionnaire		Before bariatric surgery
Secondary	Food quality using the Food Frequency Questionnaire		3 months after bariatric surgery
Secondary	Food quality using the Food Frequency Questionnaire		6 months after bariatric surgery
Secondary	Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry		Before bariatric surgery
Secondary	Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry		3 months after bariatric surgery
Secondary	Persistant organic pollutants measured by high-resolution chromatography combined with high-resolution mass spectrometry		6 months after bariatric surgery
Secondary	AMP-activated protein kinase		Before bariatric surgery
Secondary	AMP-activated protein kinase		3 months after bariatric surgery
Secondary	AMP-activated protein kinase		6 months after bariatric surgery
Secondary	Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry		Before bariatric surgery
Secondary	Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry		3 months after bariatric surgery
Secondary	Inflammation in adipose tissue using qRT-PCR, immunoblotting and immunohistochemistry		6 months after bariatric surgery