Regional Adipose Tissue Characteristics in Type II Diabetes

NCT ID: NCT06599047

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Non-Obese Group (Lean)

Healthy participants without obesity

No interventions assigned to this group

Bariatric Patients without Diabetes

Participants with obesity undergoing bariatric surgery

No interventions assigned to this group

Bariatric surgery patients with diabetes

Participants with diabetes undergoing bariatric surgery

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Concordia University, Montreal

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Santosa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Concordia University (School of Health)

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sylvia Santosa, R.D., PhD.

Role: CONTACT

514-848-2424 ext. x5841

Facility Contacts

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Sylvia Santosa, R.D, PhD

Role: primary

514.848.2424 ext. x5841

Role: backup

Muhammad Ilyas Nadeem, PhD Candidate

Role: backup

Other Identifiers

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90000059

Identifier Type: -

Identifier Source: org_study_id

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