Who Will Benefit From Bariatric Surgery for Diabetes?
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Surgical cohort Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery |
Procedure: Roux-en-Y gastric bypass (RYGB)
Bariatric surgery
|
| Control Healthy volunteers with normal body mass index |
Outcome Measures
Primary Outcome Measures
- Diabetes remission (partial or complete) [1 year]
- Diabetes remission (complete) [1 year]
Secondary Outcome Measures
- Waist circumference, waist/hip ratio (cm) [1 year]
- Body mass index (kg/m2) [1 year]
- Weight loss [1 year]
- Change in visceral adipose tissue [1 year]
Dual Energy Xray Absorptiometry measurement (DEXA)
- Change in visceral adipose tissue [1 year]
Magnetic resonance imaging (MRI) measurement
- Change in ectopic fat [1 year]
MRI measurement
Other Outcome Measures
- Change in epigenetic data in tissues. [1 year]
- Changes in the transcriptome in tissues [1 year]
- Changes in gut hormone profiles [1 year]
- Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis [1 year]
- Changes in gut microbiome [1 year]
Eligibility Criteria
Criteria
Bariatric surgery group
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Current pregnancy
-
Inability to give informed consent
-
Type 1 diabetes
-
Low fasting C-peptide
-
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
-
Current smoker
-
Participation in another (interventional) trial within the last 3 months
-
Unable to understand English
Healthy volunteers
Inclusion criteria:
-
Aged 18-80 years
-
Male or female
-
Body mass index 19 - 25 kg/m2
-
Stable weight for at least three months
Exclusion criteria:
-
Abnormal glucose tolerance and fasting glucose
-
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imperial College Healthcare NHS Trust | London | Greater London | United Kingdom | W12 0HS |
Sponsors and Collaborators
- Imperial College London
- National Institute for Health Research, United Kingdom
Investigators
- Principal Investigator: Tricia Tan, MB ChB, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRAS:231300