ClinicalTrials.gg
RecruitingNCT06599047Updated Oct 22, 2024

Regional Adipose Tissue Characteristics in Type II Diabetes

An observational study in Obesity and Type 2 Diabetes, Bariatric Patients Undergoing Bariatric Surgery and Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery, sponsored by Concordia University, Montreal. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Concordia University, Montreal · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started May 2016; still recruiting 10 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
140
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 140 is close to the median of 132 across 1,338 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Concordia University, Montreal is the lead sponsor of 22 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
140 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Non-Obese Group (Lean)

    Healthy participants without obesity

  • Bariatric Patients without Diabetes

    Participants with obesity undergoing bariatric surgery

  • Bariatric surgery patients with diabetes

    Participants with diabetes undergoing bariatric surgery

06

What researchers measure

Primary outcomes

  1. Immune Cell Quantification

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

    Time frame: 5 years

  2. Pre-adipocytes and adipocyte characteristics

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

    Time frame: 5 years

  3. Blood Inflammatory Markers

    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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Concordia University (School of Health)
    Montreal, Quebec H4B 1R6, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2016 (actual). Primary completion is estimated for Apr 2025, 107 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2024
First posted
Sep 19, 2024
StartActual
May 1, 2016
Primary completionEst.
Apr 2025
CompletionEst.
Dec 2025
Last update
Oct 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06599047
Lead sponsor
Concordia University, Montreal
Responsible party
Sylvia Santosa (Professor, Concordia University, Montreal) — Principal investigator
First posted
Sep 19, 2024
Start date
May 1, 2016
Primary completion
Apr 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

Sylvia Santosa, R.D., PhD.
Contact
s.santosa@concordia.ca
514-848-2424 ext. x5841

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion