Who Will Benefit From Bariatric Surgery for Diabetes?

Study Overview
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Brief Summary
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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.

Official Title
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Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Procedure: Roux-en-Y gastric bypass (RYGB)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical cohort<br>Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery | Procedure: Roux-en-Y gastric bypass (RYGB)<br>* Bariatric surgery<br>|
| Control<br>Healthy volunteers with normal body mass index | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes remission (partial or complete) |  | 1 year | 
| Diabetes remission (complete) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference, waist/hip ratio (cm) |  | 1 year | 
| Body mass index (kg/m2) |  | 1 year | 
| Weight loss |  | 1 year | 
| Change in visceral adipose tissue | Dual Energy Xray Absorptiometry measurement (DEXA) | 1 year | 
| Change in visceral adipose tissue | Magnetic resonance imaging (MRI) measurement | 1 year | 
| Change in ectopic fat | MRI measurement | 1 year |