NCT03842475

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2018Oct 2028

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2028

Expected
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

6.3 years

First QC Date

January 31, 2019

Last Update Submit

April 18, 2023

Conditions

Diabetes Mellitus, Type 2Obesity

Outcome Measures

Primary Outcomes (2)

  • Diabetes remission (partial or complete)

    1 year

  • Diabetes remission (complete)

    1 year

Secondary Outcomes (6)

  • 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

  • Change in visceral adipose tissue

    1 year

  • +1 more secondary outcomes

Other Outcomes (5)

  • Change in epigenetic data in tissues.

    1 year

  • Changes in the transcriptome in tissues

    1 year

  • Changes in gut hormone profiles

    1 year

  • +2 more other outcomes

Study Arms (2)

Surgical cohort

Patients with type 2 diabetes undergoing Roux-en-Y gastric bypass surgery

Procedure: Roux-en-Y gastric bypass (RYGB)

Control

Healthy volunteers with normal body mass index

Interventions

Roux-en-Y gastric bypass (RYGB)PROCEDURE

Bariatric surgery

Surgical cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 150 patients recruited to completion from Imperial Weight Centre. Up to 60 healthy volunteers

You may qualify if:

  • Males and females planning to undergo RYGB
  • 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

You may not qualify if:

  • 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
  • Aged 18-80 years
  • Male or female
  • Body mass index 19 - 25 kg/m2
  • Stable weight for at least three months
  • Abnormal glucose tolerance and fasting glucose
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, Greater London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

  • Kenkre JS, Ahmed AR, Purkayastha S, Malallah K, Bloom S, Blakemore AI, Prevost AT, Tan T. Who will benefit from bariatric surgery for diabetes? A protocol for an observational cohort study. BMJ Open. 2021 Feb 10;11(2):e042355. doi: 10.1136/bmjopen-2020-042355.

    PMID: 33568372DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Tricia Tan, MB ChB

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia S Kenkre, MB BChir

CONTACT

+44208383242imperial.bariatricstudy@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 15, 2019

Study Start

October 1, 2018

Primary Completion

January 1, 2025

Study Completion (Estimated)

October 5, 2028

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)