Clinical trial NCT06599047: Regional Adipose Tissue Characteristics in Type II Diabetes
Official title: Regional Adipose Tissue Characteristics in Type II Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2024-09-19
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Immune Cell Quantification
timeFrame: 5 years
measure: Pre-adipocytes and adipocyte characteristics
timeFrame: 5 years
measure: Blood Inflammatory Markers
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Concordia University (School of Health)
state: Quebec
Study officials:
References: