NCT01365416

Brief Summary

The prevalence of morbid obesity (BMI \> 40 kg/m2) is increasing rapidly in the UK, but the investigators lack a coherent strategy for detailed assessment and treatment of the individuals affected, who are at high risk of morbidity and early mortality. The investigators already know that more than 1 in 20 severely-obese individuals have a simple genetic cause of their obesity (usually inherited in an autosomal dominant pattern. Bariatric surgery is the most effective treatment for morbid obesity and certain surgeries can result in the remission of type 2 diabetes. However, some patient fail to achieve the weight loss or experience complications and re-operations. The investigators are unable to predict the outcomes of bariatric surgery particularly in relation to type 2 diabetes remission which is crucial for the assessment of risk to benefit balance before wider future applications of the surgery. The investigators want to investigate the mechanism underlying Type 2 diabetes remission after bariatric surgery by A) examining the effect of Mendelian forms of obesity and diabetes on T2D remission, B) studying changes in expression profiling patterns in insulin-responsive tissues, C) identifying of eQTLs, and of other genetic variations affecting T2D remission and D) studying the role of epigenetic variation in T2D remission.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

December 9, 2011

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

14.1 years

First QC Date

June 1, 2011

Last Update Submit

November 10, 2023

Conditions

Keywords

diabetesdiabetes remissionobesitybariatric surgerygene expressiongenetic variationmetabolomicsmetabonomicsepigenetic variationmutations

Eligibility Criteria

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

2000 obese patients

You may qualify if:

  • BMI \>28 kg/m2
  • Age between 18-65 years

You may not qualify if:

  • donation of blood within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial Weight Centre

London, United Kingdom

Location

Related Publications (1)

  • Murphy J, Uttamlal T, Schmidtke KA, Vlaev I, Taylor D, Ahmad M, Alsters S, Purkayastha P, Scholtz S, Ramezani R, Ahmed AR, Chahal H, Darzi A, Blakemore AIF. Tracking physical activity using smart phone apps: assessing the ability of a current app and systematically collecting patient recommendations for future development. BMC Med Inform Decis Mak. 2020 Feb 3;20(1):17. doi: 10.1186/s12911-020-1025-3.

Biospecimen

Retention: SAMPLES WITH DNA

SALIVA BLOOD URINE AND FAECES TISSUE (Muscle, Liver, Subcutaneous fat, Visceral fat)

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alexandra I Blakemore, Prof

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

December 9, 2011

Primary Completion

December 29, 2025

Study Completion

December 29, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations