Regional Adipose Tissue Characteristics in Type II Diabetes

NCT06599047 | Recruiting

• 1 other identifier: 90000059
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

obesity; Type 2 diabetes; Bariatric Surgery; Adipose Tissue Characterization; Adipose Tissue Inflammation

Outcome Measures

Primary Outcomes (3)

• Immune Cell Quantification

  Flow Cytometry will be used to quantify immune cells in the fat tissue.

  5 years

• Pre-adipocytes and adipocyte characteristics

  Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.

  5 years

• Blood Inflammatory Markers

  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

  5 years

Study Arms (3)

Non-Obese Group (Lean)

Healthy participants without obesity

Bariatric Patients without Diabetes

Participants with obesity undergoing bariatric surgery

Bariatric surgery patients with diabetes

Participants with diabetes undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Diabetes and Obese groups will be recruited from patients scheduled to undergo bariatric surgery in Montréal and the lean participants will be recruited from healthy patients scheduled to undergo general surgery.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Concordia University, Montreal: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Concordia University (School of Health)

Montreal, Quebec, H4B 1R6, Canada

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Sylvia Santosa, R.D., PhD.

CONTACT

514-848-2424; s.santosa@concordia.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2016
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)