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Regional Adipose Tissue Characteristics in Type II Diabetes

C

Concordia University, Montreal

Status

Enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT06599047
90000059

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

140 participants in 3 patient groups

Non-Obese Group (Lean)
Description:
Healthy participants without obesity
Bariatric Patients without Diabetes
Description:
Participants with obesity undergoing bariatric surgery
Bariatric surgery patients with diabetes
Description:
Participants with diabetes undergoing bariatric surgery

Trial contacts and locations

1

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Central trial contact

Sylvia Santosa, R.D., PhD.

Data sourced from clinicaltrials.gov

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