Menu
Recruiting NCT06599047

Regional Adipose Tissue Characteristics in Type II Diabetes

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obesity and Type 2 Diabetes, Bariatric Patients Undergoing Bariatric Surgery, Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery, Adipose Tissue Inflammation. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Immune Cell Quantification [Time frame: 5 years]
  • Pre-adipocytes and adipocyte characteristics [Time frame: 5 years]
  • Blood Inflammatory Markers [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Concordia University (School of Health) — Montreal

Identifiers

NCT: NCT06599047 · 90000059

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗