Diabetes Mellitus, Type 2, Obesity
Conditions
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.
Interventions
PROCEDURERoux-en-Y gastric bypass (RYGB)
Bariatric surgery
Sponsors
National Institute for Health Research, United Kingdom
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes remission (partial or complete) | 1 year |
| Diabetes remission (complete) | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (kg/m2) | 1 year | — |
| Waist circumference, waist/hip ratio (cm) | 1 year | — |
| Weight loss | 1 year | — |
| Change in visceral adipose tissue | 1 year | Dual Energy Xray Absorptiometry measurement (DEXA) |
| Change in ectopic fat | 1 year | MRI measurement |
Other
| Measure | Time frame |
|---|---|
| Changes in the transcriptome in tissues | 1 year |
| Histological scoring of specimens for Non-alcoholic fatty liver disease/Non-alcoholic steatohepatitis | 1 year |
| Changes in gut microbiome | 1 year |
| Changes in gut hormone profiles | 1 year |
| Change in epigenetic data in tissues. | 1 year |
Countries
United Kingdom
Contacts
Primary ContactJulia S Kenkre, MB BChir
Outcome results
None listed