Obesity and Type 2 DiabetesNCT06599047
Regional Adipose Tissue Characteristics in Type II Diabetes
An observational study of Obesity and Type 2 Diabetes and Bariatric Patients Undergoing Bariatric Surgery, run by Concordia University, Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Type 2 Diabetes, Bariatric Patients Undergoing Bariatric Surgery, Adipose Tissue Dysfunction Type 2 Diabetes Mellitus Bariatric Surgery
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2016to Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Concordia University (School of Health)
Montreal, Quebec, H4B 1R6
Sylvia Santosa, R.D, PhD, 514.848.2424 ext. x5841, s.santosa@concordia.ca
ilyas.nadeem02@gmail.com
About this study
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.
- Conditions
- 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
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Cell Quantification
Flow Cytometry will be used to quantify immune cells in the fat tissue.
Measured: 5 years
Pre-adipocytes and adipocyte characteristics
Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 May 2016
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Sylvia Santosa, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599047
- Sponsor's protocol ID
- 90000059
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Adipose Tissue Characteristics in Type II Diabetes
- ClinicalTrials.gov ID
- NCT06599047
- Acronym / sponsor ID
- 90000059
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 May 2016 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune Cell Quantification
Time frame: 5 years
Flow Cytometry will be used to quantify immune cells in the fat tissue.
Pre-adipocytes and adipocyte characteristics
Time frame: 5 years
Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes and Bariatric Patients Undergoing Bariatric Surgery, run by Concordia University, Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Santosa, R.D., PhD. (514-848-2424 ext. x5841, s.santosa@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Cell Quantification (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.