Brief 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.4 years study duration

Study Start

First participant enrolled

April 25, 2012

Completed

9.9 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed

17 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed

Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

10.3 years

First QC Date

March 14, 2022

Last Update Submit

March 22, 2022

Conditions

Obesity

Keywords

Bariatric surgeryPersistant organic pollutantsType 2 diabetes

Outcome Measures

Primary Outcomes (2)

Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
Before bariatric surgery
Adipose tissue fibrosis using qRT-PCR, immunoblotting, histochemistry and immunohistochemistry
6 months after bariatric surgery

Secondary Outcomes (15)

Calory intake
Before bariatric surgery
Calory intake
3 months after bariatric surgery
Calory intake
6 months after bariatric surgery
Food quality using the Food Frequency Questionnaire
Before bariatric surgery
Food quality using the Food Frequency Questionnaire
3 months after bariatric surgery
+10 more secondary outcomes

Study Arms (3)

Obese with type 2 diabetes

Procedure: Bariatric surgeryOther: Blood samplingOther: Blood pressureOther: Anthropometric measurementsOther: Body compositionOther: Resting metabolic rateOther: Food intakeProcedure: Adipose tissue biopsy

Obese insulin-sensitive