Morbid ObesityNCT03038373
Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery
An observational study of Morbid Obesity and Type2 Diabetes, run by Dasman Diabetes Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Type2 Diabetes
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- adults
- Type 2 diabetes <5 years
- male and female,
- resident of Kuwait,
- who agreed to participate in the study
Who cannot join
- pregnancy,
- malignancy,
- type 1 diabetes,
- type 2 diabetes with more than 5 years,
- and history with overt heart and/or kidney failure
About this study
Official title: 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.
Read the 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.
- Conditions
- Morbid Obesity, Type2 Diabetes
- Being tested
- Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy Receives: Procedure: Laparoscopic Sleeve Gastrectomy | |
| Group II | Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy Receives: Procedure: Laparoscopic Sleeve Gastrectomy | |
| Group III | Lean Diabetics, No surgery | |
| Group IV | Lean Non Diabetics, No surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startApr 2012
- Primary completionJun 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kuwait University
- Responsible party
- Sponsor
- Investigators
- Hossein Arefanian, PhD, Principal investigator, Dasman Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038373
- Sponsor's protocol ID
- RA-2011-014
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2017
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32832558
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03038373
- Acronym / sponsor ID
- RA-2011-014
- Conditions
- Morbid Obesity, Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Collaborators
- Kuwait University
- Study start
- Apr 2012
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Laparoscopic Sleeve GastrectomyMorbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy |
| Group II | – | Procedure: Laparoscopic Sleeve GastrectomyMorbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy |
| Group III | – | –Lean Diabetics, No surgery |
| Group IV | – | –Lean Non Diabetics, No surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- adults
- Type 2 diabetes <5 years
- male and female,
- resident of Kuwait,
- who agreed to participate in the study
Key exclusion criteria (5 listed)
- pregnancy,
- malignancy,
- type 1 diabetes,
- type 2 diabetes with more than 5 years,
- and history with overt heart and/or kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Sleeve GastrectomyLaparoscopic Sleeve Gastrectomy will be conducted based on standard protocol. | Procedure or surgery | Group I, Group II |
Primary outcome
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%
Time frame: 1 year
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 32832558Al 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hossein Arefanian, PhD principal investigator
Dasman Diabetes Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Type2 Diabetes, run by Dasman Diabetes Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5% (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03038373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.