Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery

Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery-focused on Beta Cell Function and Insulin Sensitivity Changes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Morbid Obesity; Type2 Diabetes
• Intervention / Treatment: Procedure: Laparoscopic Sleeve Gastrectomy

Detailed Description

In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy (LSG). All participants will be assessed by members of a multidisciplinary obesity team including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have input into patient selection.

Briefly the study will be explained to the each participant, and after his/her agreement, the informed Consent Form will be deliver to him/her for completion and signature. Within a week before surgery each enrolled participant of group I and II will be subjected to a medical questionnaire and other routine laboratory analyses before surgery such as fasting glucose, liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT) will be performed and blood samples will be collected for further analysis as it is described in the protocol.

Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and 360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from these participants will be harvested during of the LSG (days 0). Participants in group I will be asked to monitor their fasting blood glucose level everyday at early morning and the dose of anti-hyperglycemia medications will be adjusted by the recommendation provided by the physician member of team. This data will be recorded as their continuous blood glucose monitoring.

Group III and IV participants, as control groups with no surgical intervention, will be subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just one visit.

All demographic and clinical information collected from the participants will be recorded in the information form identified by identification number (ID number). Only samples from the cases that do not have any post-surgery related complications or not have any emergency clinical condition will be used for genomics and proteomics analysis.

• Study Type: Observational
• Enrollment (Anticipated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• adults
• Type 2 diabetes <5 years
• male and female,
• resident of Kuwait,
• who agreed to participate in the study

Exclusion Criteria:

• pregnancy,
• malignancy,
• type 1 diabetes,
• type 2 diabetes with more than 5 years,
• and history with overt heart and/or kidney failure

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy	Procedure: Laparoscopic Sleeve Gastrectomy; Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Group II; Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy	Procedure: Laparoscopic Sleeve Gastrectomy; Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
Group III; Lean Diabetics, No surgery
Group IV; Lean Non Diabetics, No surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dasman Diabetes Institute
• Collaborators: Kuwait University
• Investigators: Principal Investigator: Hossein Arefanian, PhD, Dasman Diabetes Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
• Other Study ID Numbers: RA-2011-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO