NCT04332354

Brief Summary

The aim of this observational prospective monocentric study is to examine glycemic patterns in adult T2D patients candidates to bariatric surgery, by using a continuous glucose monitoring (CGM) sensor over 14 days post-surgery, in order to search for indicators predicting T2D remission 1 year after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 31, 2020

Last Update Submit

March 31, 2020

Conditions

Type 2 Diabetes Mellitus in ObeseBariatric Surgery Candidate

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • glycemic profile after bariatric surgery

    CGM recordings 4-14 days of the immediate postoperative period

    4-14 days recordings

Secondary Outcomes (2)

  • glycemic profile before bariatric surgery

    5 days recordings

  • identification of predictive factors for diabetes remission 1 year after surgery

    5 days recordings for CGM

Study Arms (1)

T2D diabetes obese subjects

Patients have T2D diabetes and are candidates for bariatric surgery. They will receive routine cares and follow-up and will have CGM measurement before and 2 weeks following the surgery

Other: routine care. No intervention

Interventions

routine care. No interventionOTHER

no intervention

T2D diabetes obese subjects

Eligibility Criteria

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

T2D, obesity (BMI\>35), candidates for metabolic surgery oral or injectable anti diabetic treatments including insulin injections or pump therapy

You may qualify if:

  • type 2 diabetes and obesity (BMI\> 35)
  • treated with oral anti-diabetic medication and/or insulin therapy
  • candidate for bariatric surgery

You may not qualify if:

  • refusal of CGM recordings
  • refusal of bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 2, 2020

Study Start

March 30, 2016

Primary Completion

March 30, 2018

Study Completion

May 30, 2018

Last Updated

April 2, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share