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Regional Adipose Tissue Characteristics in Type II Diabetes

Regional Adipose Tissue Characteristics in Type II Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06599047
Enrollment
140
Registered
2024-09-19
Start date
2016-05-01
Completion date
2025-12-31
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
CollaboratorOTHER
Concordia University, Montreal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Immune Cell Quantification5 yearsFlow Cytometry will be used to quantify immune cells in the fat tissue.
Pre-adipocytes and adipocyte characteristics5 yearsCellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Blood Inflammatory Markers5 yearsThe 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

Countries

Canada

Contacts

Primary ContactSylvia Santosa, R.D., PhD.
s.santosa@concordia.ca514-848-2424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026