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New treatment option for Diabetes Mellitus Type 2
Official title Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery
ClinicalTrials.gov ID: NCT05934409
What this study is testing
What is Nicotinic Acid?
Nicotinic Acid is an investigational medicine, being studied as a potential treatment for diabetes mellitus type 2.
Also referred to as Niacin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The present protocol aims to understand and establish whether there is a causal link between adipose tissue metabolic remodeling and Type 2 Diabetes (T2D) remission after bariatric surgery. All participants will have a bariatric surgery, divided in 2 groups: with or without T2D.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Aged 18 to 65
- BMI 35 kg/m2
- Diagnosed T2D - according to Diabetes Canada diagnostics criteria.
- Diagnosed non-T2D - according to Diabetes Canada diagnostics criteria.
- Women with a negative serum pregnancy test.
You likely can't join if
- Treatment with an oral contraceptive;
- Treatment with fibrate, thiazolidinedione, insulin, or beta-blocker, drugs that affect metabolism and cannot be stopped temporarily or which have...
- Presence of overt cardiovascular disease, liver or renal failure or other uncontrolled medical conditions;
- Any other contraindication to surgery or to temporarily suspending current medications for diabetes, lipids or hypertension;
- Smoking or consumption of more than 2 alcoholic beverages per day;
- Any contraindication to MRI;
See the full eligibility criteria
- Aged 18 to 65
- BMI 35 kg/m2
- Diagnosed T2D - according to Diabetes Canada diagnostics criteria.
- Diagnosed non-T2D - according to Diabetes Canada diagnostics criteria.
- Women with a negative serum pregnancy test.
- Treatment with an oral contraceptive;
- Treatment with fibrate, thiazolidinedione, insulin, or beta-blocker, drugs that affect metabolism and cannot be stopped temporarily or which have long-lasting effects;
- Presence of overt cardiovascular disease, liver or renal failure or other uncontrolled medical conditions;
- Any other contraindication to surgery or to temporarily suspending current medications for diabetes, lipids or hypertension;
- Smoking or consumption of more than 2 alcoholic beverages per day;
- Any contraindication to MRI;
- A Diabetes Remission (DiaRem) score \>8 (low probability of T2D remission);
- Having participated to a research study with exposure to radiation in the last two years before the start of the study;
- Pregnant or breastfeeding women;
- Patients weighing more than 200 kg to respect the weight and gantry limit of our MRI and PET/CT scanners.
- Being allergic to eggs
The study team makes the final eligibility decision.
Where it's taking place
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sherbrooke, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.