Who Will Benefit From Bariatric Surgery for Diabetes?

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Procedure: Roux-en-Y gastric bypass (RYGB)

• Registration Number: NCT03842475
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-19
• Primary Completion: 2025-01-01
• Study Completion: 2028-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical cohort	Roux-en-Y gastric bypass (RYGB)	Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery

Primary Outcome Measures

Name	Time	Method
Diabetes remission (partial or complete)	1 year
Diabetes remission (complete)	1 year

Secondary Outcome Measures

Name	Time	Method
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	Magnetic resonance imaging (MRI) measurement
Change in ectopic fat	1 year	MRI measurement

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, Greater London, United Kingdom