Actively Recruiting
Regional Adipose Tissue Characteristics in Type II Diabetes
Led by Concordia University, Montreal · Updated on 2024-10-22
140
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
C
Concordia University, Montreal
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how fat tissue in different parts of the body, especially abdominal fat, relates to the development of diseases like type 2 diabetes and cardiovascular disease. The study aims to understand how abdominal fat causes or contributes to these diseases and how the diseases may affect fat tissue. This observational study involves adults aged 18 to 65, including people with obesity, diabetes, and lean individuals. The study will include 140 participants divided into three groups: 40 people with obesity undergoing bariatric surgery, 40 with diabetes also undergoing bariatric surgery, and 60 healthy lean participants undergoing general abdominal surgery. Participants are recruited from hospital patients awaiting surgery and from the general population. This design allows comparison of fat tissue characteristics across these groups. Participants will be assessed over up to 5 years, focusing on immune cell counts, features of fat cells, and blood markers of inflammation. Researchers will collect data during surgery and follow up with participants to monitor changes. The study will provide valuable information on fat tissue and its role in metabolic diseases to improve understanding of these conditions.
CONDITIONS
Brief Title
Regional Adipose Tissue Characteristics in Type II Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (premenopausal or postmenopausal) aged 18 to 65 years
- Scheduled for bariatric surgery (for participants with obesity) or general abdominal surgery lasting less than 1.5 hours (for lean participants)
- Body mass index (BMI) of 30 kg/m2 or higher for participants with obesity
- Stable weight for at least two months before the first pre-op visit
You will not qualify if you...
- Current smoking
- Kidney problems defined by creatinine clearance below 60 ml/minute
- Uncontrolled hypothyroidism
- Presence of other medical conditions besides type 2 diabetes, except controlled hypertension, controlled hypothyroidism, or controlled dyslipidemia
- Use of prescribed medications affecting study outcomes, except stable doses of metformin, DPP-4 inhibitors, alpha-glucosidase inhibitors, or stable doses of blood pressure or lipid-lowering drugs for at least 3 months
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo bariatric or general abdominal surgery and receive immediate post-operative care.
1 surgery visit (in-person)
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess immune cells, adipocyte characteristics, and blood inflammatory markers.
Periodic visits for assessments over 5 years
Trial Site Locations
Total: 1 location
1
Concordia University (School of Health)
Montreal, Quebec, Canada, H4B 1R6
Actively Recruiting
Research Team
S
Sylvia Santosa, R.D., PhD.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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