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NCT Number: NCT06599047

Regional Adipose Tissue Characteristics in Type II Diabetes

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.

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Key information

Conditions

Obesity and Type 2 Diabetes Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery Adipose Tissue Inflammation Bariatric Patients Undergoing Bariatric Surgery Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Concordia University (School of Health)

Montreal, Quebec, H4B 1R6, Canada

Location status: Recruiting

Location contact

Muhammad Ilyas Nadeem, PhD Candidate

CONTACT

Sylvia Santosa, R.D, PhD

CONTACT

[email protected]

514.848.2424 ext. x5841

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Immune Cell Quantification

    Time frame: 5 years

    Flow Cytometry will be used to quantify immune cells in the fat tissue.

  2. Pre-adipocytes and adipocyte characteristics

    Time frame: 5 years

    Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.

  3. Blood Inflammatory Markers

    Time frame: 5 years

    The 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvia Santosa, R.D., PhD.

CONTACT

[email protected]

514-848-2424 ext. x5841

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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