Regional Adipose Tissue Characteristics in Type II Diabetes

Recruiting

• Conditions: Obesity and Type 2 Diabetes; Bariatric Patients Undergoing Bariatric Surgery; Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery; Adipose Tissue Inflammation

• Registration Number: NCT06599047
• Lead Sponsor: Concordia University, Montreal

Brief Summary

Fat tissue in different parts of the body has different characteristics. Several studies have associated abdominal fat to an increased risk for multiple metabolic diseases, such as type 2 diabetes and cardiovascular disease, compared with fat located under the skin at the hips and thighs. However, the investigators do not know how the abdominal fat causes or contributes to the development of these diseases or how the development of these disease may in turn cause or contribute to changes in the fat tissue. The general objective of this study is to understand these mechanisms.

To investigate these questions, the study will recruit 140 participants, both men and women aged 18-65 years. The participants will be divided into three groups: 40 people with obesity, 40 with diabetes, and 60 lean individuals. Participants will be recruited from patients at the CIUSSS du Nord-de-l'Île-de Montréal - Hôpital du Sacré-Coeur de Montréal who are awaiting bariatric or general abdominal surgery, as well as from the general population in the Montreal area.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Men, premenopausal and postmenopausal females between 18-65 years
• Anticipating having bariatric surgery (participants with obesity) or general surgery in the abdominal area (normal weight participants) with a duration of less than 1.5 hours.
• BMI 30 kg / m2 (participants with obesity)
• Weight Stable for a minimum of two months prior to the first pre-op visit

Exclusion Criteria

• Smoking
• Renal impairment defined by creatinine clearance; 60 ml/minute
• Uncontrolled hypothyroidism
• No comorbidity other than diabetes type II Exceptions: controlled hypertension, hypothyroidism controlled, controlled dyslipidemia
• Use prescribed medication that affect our outcomes E.g. Exceptions include metformin, DPP-4 inhibitors, inhibitors of the α-glucosidase, hypotensive with a stable dose for 3 months lipid lowering with a stable dose for 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune Cell Quantification	5 years	Flow Cytometry will be used to quantify immune cells in the fat tissue.
Pre-adipocytes and adipocyte characteristics	5 years	Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Blood Inflammatory Markers	5 years	The inflammatory cytokines (e.g. IL6, TNFα), chemokines (e.g. monocyte chemoattractant protein-1), genomics, and adipokines (e.g. leptin, adiponectin) in blood and adipose tissue via PCR, luminex or ELISA will be measured

Trial Locations

Locations (1)

Concordia University (School of Health); 🇨🇦 Montreal, Quebec, Canada