Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery
1 other identifier
observational
80
0 countries
N/A
Brief Summary
The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes in the morbid obese patients after laparoscopic sleeve gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2012
Longer than P75 for all trials
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
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 6, 2022
October 1, 2021
10.2 years
January 30, 2017
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level \< 7.0 mmol and HbA1c \<6.5%
1 year
Study Arms (4)
Group I
Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy
Group II
Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy
Group III
Lean Diabetics, No surgery
Group IV
Lean Non Diabetics, No surgery
Interventions
Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Eligibility Criteria
Group I and II: eligible candidates will be selected from waiting list of the surgeon, Group III: volunteer lean type 2 diabetics from patient list of Dasman Diabetes Institute Group IV: Invitation to volunteer
You may qualify if:
- adults
- Type 2 diabetes \<5 years
- male and female,
- resident of Kuwait,
- who agreed to participate in the study
You may not qualify if:
- pregnancy,
- malignancy,
- type 1 diabetes,
- type 2 diabetes with more than 5 years,
- and history with overt heart and/or kidney failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dasman Diabetes Institutelead
- Kuwait Universitycollaborator
Related Publications (1)
Al Shawaf E, Al-Ozairi E, Al-Asfar F, Mohammad A, Al-Beloushi S, Devarajan S, Al-Mulla F, Abubaker J, Arefanian H. Atherogenic Index of Plasma (AIP) a Tool to Assess Changes in Cardiovascular Disease Risk Post Laparoscopic Sleeve Gastrectomy. J Diabetes Res. 2020 Aug 1;2020:2091341. doi: 10.1155/2020/2091341. eCollection 2020.
PMID: 32832558DERIVED
Biospecimen
Whole blood, serum, plasma, peripheral blood mononuclear cell (PBMC), fat tissues, muscle tissues, remnant surgical tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hossein Arefanian, PhD
Dasman Diabetes Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
January 31, 2017
Study Start
April 1, 2012
Primary Completion
June 1, 2022
Study Completion
December 1, 2024
Last Updated
April 6, 2022
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share