NCT03842475Recruiting
Who Will Benefit From Bariatric Surgery for Diabetes?
Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
Source: ClinicalTrials.gov · Last updated 19 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 210 (estimated)
- First submitted
- 31 Jan 2019
- Start date
- 1 Oct 2018
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- Imperial College London
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT03842475
What you commit to
- Study type: Observational
- Planned participants: 210
- From 1 Oct 2018 to the primary completion date, 1 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 1 diabetes
- Secondary diabetes or absence of β-cell function
- Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy
- History of any medical, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study
Lab values
- Abnormal glucose tolerance and fasting glucose
Other
- Current pregnancy
- Inability to give informed consent
- Low fasting C-peptide
- Current smoker
- Participation in another (interventional) trial within the last 3 months
- Unable to understand English
- Healthy volunteers
- Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
- Pregnancy or breastfeeding
- Unable to maintain adequate contraception for the duration of the study
- Donated blood during the preceding 3 months or intention to do so before the end of the study
- Current smoker
- Participation in another trial within the last 3 months
- Unable to understand English
Who the study is looking for
- Males and females planning to undergo RYGB
- 18-80 years
- Type 2 diabetes mellitus or prediabetes
- Stable weight for at least 3 months
- Obese (BMI ≥30kg/m2)
- Eligible for surgery on the National Health Service (NHS) under The National Institute for Health and Care Excellence (NICE) 2014 criteria
- Aged 18-80 years
- Male or female
- Body mass index 19 - 25 kg/m2
- Stable weight for at least three months
Criteria the registry did not label
- Bariatric surgery group
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.