Type 2 Diabetes MellitusNCT04058730
Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG & SMM
A study testing Laparoscopic Roux en Y Gastric by pass surgery, Laparoscopic Sleeve Surgery and Standard Medical Management in people with Type 2 Diabetes Mellitus, run by Max Institute of Minimally Access, Metabolic & Bariatric Surgery at 2 sites in India.
Trial summary
A Comparative Interventional Study to Evaluate the Role of Laparoscopic Roux-en-Y Gastric Bypass (LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard Medical Management (SMM) in Patients of Type II Diabetes Mellitus (DM) and Body Mass Index ( BMI) Between 27.5 - 32.5 kg / m²." Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Laparoscopic Roux en Y Gastric by pass surgery, Laparoscopic Sleeve Surgery and Standard Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Apr 2015to Dec 2021
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30 to 60 years at the time of enrollment.
- Type II DM present according to standard diagnostic criteria (ADA 2010) for at least 6 months.
- Body mass Index (BMI) between 27.5 - 32.5 kg / m².
- Waist circumference>90 cm if male; >80cm if female.
- Demonstrated to have inadequate control of diabetes defined as HbA1c >8.0mg/dl
- Patients who have given written informed consent.
- Ability to complete the run in for dietary intake and exercise
- Willingness and ability to comply with the follow up protocol, including returns to the clinical center for visits at 1, 3, 12, 24, months post surgery.
Who cannot join
- TypeII DM of more than 10 years duration.
- Weight loss of more than 9Kgs in preceding six months.
- Currently pregnant or planning to become pregnant.
- Cancer requiring treatment in the past 5 years
- Active HIV or tuberculosis
- CVD event within 6 months prior to enrollment
Show all 20Show fewer
- Pulmonary embolus in past 6 months
- CVD manifesting any of the following criteria: unstable angina pectoris or angina pectoris at rest; a history of cardiac arrest; complex ventricular arrhythmia at rest or with exercise; uncontrolled atrial fibrillation(heart rate of 100 beats per minute or more); New York Heart Association Class III or IV congestive her failure; acute myocarditis, pericarditis or hypertrophic myocardiopathy; clinically significant aortic stenosis; left bundle block or cardiac pace maker unless approved by cardiologist, cardiac defibrillator; history of aortic aneurysum or at least 7cm in diameter or aortic aneurysum repair; resting heat rate<45 beats per minute or >100 beats per minute; heart transplantation.
- Serum creatinine >1.4mg/dl(women) or 1.5mg/dl(men)
- History of PE or DVT within 6 months
- Abnormal serum free T4 (>1.8) of thryrotropin (TSH >5.5)
- Bilirubin, aspartate amino transferase (AST) or alkaline phosphatase more than thrice the normal.
- Hospitalization for depression in past 6 months.
- Travel plans that inhibits full participation
- History of bariatric surgery, small bowel resection or extensive large bowel resection
- Chronic treatment with systematic corticosteroids
- Current diagnosis of schizophrenia, or other psychotic disorder, bipolar disorder, alcohol abuse or substance abuse.
- Alcoholic or drug addict ( daily consumption of alcohol >60ml in males and >30ml in females)
- Unstable proliferative retinopathy
- Other medical, psychiatric, or behavioral limitations that in the judgments of the investigators may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
2 sites in 1 country.
India2 sites
Max Institute of Minimal Access Metabolic and Bariatric Surgery
New Delhi, 110017
Max Institute of Minimal Access, Metabolic & Bariatric Surgery
New Delhi, 110017
About this study
Official title: A Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG and SMM in Patients of Type II DM and BMI Between 27.5 - 32.5 kg / m²."
A Comparative Interventional Study to Evaluate the Role of Laparoscopic Roux-en-Y Gastric Bypass (LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard Medical Management (SMM) in Patients of Type II Diabetes Mellitus (DM) and Body Mass Index ( BMI) Between 27.5 - 32.5 kg / m²."
Read the detailed description
The primary objective of the study is to evaluate the role of Laparoscopic Roux-en-Y Gastric bypass(LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard medical management in patients of type II diabetes and BMI between 27.5 - 32.5 kg / m²."
- A. Partial Remission
- B. Complete Remission
- C. No Remission
Secondary Objective is to evaluate the role of LRYGB, LSG and SMM on other metabolic disorder parameters like
- Dyslipidemia
- Hypertension
- Waist Circumference
This is a study comparing the role of LRYGB, LSG and SMM in subjects suffering from Type II diabetes mellitus with BMI between 27.5 - 32.5 kg/m². Diabetic patients shall be enrolled as per the inclusion and exclusion criteria. The study treatment will be LRYGB surgery or LSG or SMM in subjects who qualify the inclusion/ exclusion criteria.
Post discharge the study subjects will be followed up at the following intervals:
1 Month, 3 Months 12 Months and 24 Months respectively At follow up subjects shall have an overall clinical examination, adverse events and complication shall be recorded and blood samples for laboratory investigation shall be collected.
Number of Subjects
Planned: 150 qualified subjects
To be Analyzed: 150 qualified subjects
Statistical Methods:
Study Population Male and female subjects 30-60 years of age with Type II Diabetes and BMI between 27.5 - 32.5 kg/m2, who fulfill all the inclusion criteria and do not meet any exclusion criteria will be enrolled into the Study.
Sample Size In this study 150 eligible subjects will be enrolled. One Fifty subjects enrolled would provide the 95% of confidence interval with 10% absolute precision.
Statistical Analysis In this study first normality of the data will be checked. Normally distributed data will be analysed by paired t-test. For non- parametric data Wilcox-on signed rank sum test will be used.
As same Subject will be examined at different time points (more than two time points) the ANOVA of Repeated measures will be used. All tests will be two-tailed and the significance level will be 0.05
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Laparoscopic Roux en Y Gastric by pass surgery, Laparoscopic Sleeve Surgery, Standard Medical Management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux en Y Gastric by pass surgeryProcedure or surgery
Laparoscopic Sleeve SurgeryProcedure or surgery
Standard Medical ManagementOther
| Study group | Role | What they receive |
|---|---|---|
| LRYGBP | Experimental | Laparoscopic Roux en Y Gastric by pass surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic RYGB is primarily a restrictive procedure with a small element of malabsorption.
Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge. Receives: Procedure: Laparoscopic Roux en Y Gastric by pass surgery |
| LSG | Experimental | Laparoscopic Sleeve Gastrectomy surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic Sleeve Gastrectomy is a pure restrictive procedure. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge Receives: Procedure: Laparoscopic Sleeve Surgery |
| SMM | Experimental | Standard Medical Management will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Standard Medical management will be as per the recommendation of ADA 2010 guidelines.
Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients 1 month, 3 months, 12 months and 24 months post consult Receives: Other: Standard Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Haemoglobin less than 6.5 mg/dl
The remission of Type II Diabetes Mellitus will be assessed on the basis of the Glycosylated Haemoglobin levels of the patient post surgery.. At 1 month, 3months, 12months, 24 months after discharge
Measured: immediately after the surgery upto 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Apr 2015
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Institute of Minimally Access, Metabolic & Bariatric Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR PRADEEP CHOWBEY, Max Institute of Minimally Access, Metabolic & Bariatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058730
- Sponsor's protocol ID
- MAMBS04
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Interventional Study to Evaluate the Role of LRYGBP, LSG and SMM in Patients of Type II DM and BMI Between 27.5 - 32.5 kg / m²."
- ClinicalTrials.gov ID
- NCT04058730
- Acronym / sponsor ID
- MAMBS04
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Max Institute of Minimally Access, Metabolic & Bariatric SurgeryUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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.
A Comparative Interventional Study to Evaluate the Role of Laparoscopic Roux-en-Y Gastric Bypass (LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard Medical Management (SMM) in Patients of Type II Diabetes Mellitus (DM) and Body Mass Index ( BMI) Between 27.5 - 32.5 kg / m²."
Detailed description
The primary objective of the study is to evaluate the role of Laparoscopic Roux-en-Y Gastric bypass(LRYGBP), Laparoscopic Sleeve Gastrectomy (LSG) and Standard medical management in patients of type II diabetes and BMI between 27.5 - 32.5 kg / m²."
- A. Partial Remission
- B. Complete Remission
- C. No Remission
Secondary Objective is to evaluate the role of LRYGB, LSG and SMM on other metabolic disorder parameters like
- Dyslipidemia
- Hypertension
- Waist Circumference
This is a study comparing the role of LRYGB, LSG and SMM in subjects suffering from Type II diabetes mellitus with BMI between 27.5 - 32.5 kg/m². Diabetic patients shall be enrolled as per the inclusion and exclusion criteria. The study treatment will be LRYGB surgery or LSG or SMM in subjects who qualify the inclusion/ exclusion criteria.
Post discharge the study subjects will be followed up at the following intervals:
1 Month, 3 Months 12 Months and 24 Months respectively At follow up subjects shall have an overall clinical examination, adverse events and complication shall be recorded and blood samples for laboratory investigation shall be collected.
Number of Subjects
Planned: 150 qualified subjects
To be Analyzed: 150 qualified subjects
Statistical Methods:
Study Population Male and female subjects 30-60 years of age with Type II Diabetes and BMI between 27.5 - 32.5 kg/m2, who fulfill all the inclusion criteria and do not meet any exclusion criteria will be enrolled into the Study.
Sample Size In this study 150 eligible subjects will be enrolled. One Fifty subjects enrolled would provide the 95% of confidence interval with 10% absolute precision.
Statistical Analysis In this study first normality of the data will be checked. Normally distributed data will be analysed by paired t-test. For non- parametric data Wilcox-on signed rank sum test will be used.
As same Subject will be examined at different time points (more than two time points) the ANOVA of Repeated measures will be used. All tests will be two-tailed and the significance level will be 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRYGBP | Experimental | Procedure: Laparoscopic Roux en Y Gastric by pass surgeryLaparoscopic Roux en Y Gastric by pass surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic RYGB is primarily a restrictive procedure with a small element of malabsorption. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge. |
| LSG | Experimental | Procedure: Laparoscopic Sleeve SurgeryLaparoscopic Sleeve Gastrectomy surgery will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Laparoscopic Sleeve Gastrectomy is a pure restrictive procedure. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients to evaluate the effect of the intervention at 1 month, 3 months, 12 months and 24 months post discharge |
| SMM | Experimental | Other: Standard Medical ManagementStandard Medical Management will be evaluated for patients of Type II DM with BMI between 27.5-32.5 kg/m2 Standard Medical management will be as per the recommendation of ADA 2010 guidelines. Glycosylated Haemoglobin will be used as a parameter to assess the status of Type II Diabetes for these patients 1 month, 3 months, 12 months and 24 months post consult |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 30 to 60 years at the time of enrollment.
- Type II DM present according to standard diagnostic criteria (ADA 2010) for at least 6 months.
- Body mass Index (BMI) between 27.5 - 32.5 kg / m².
- Waist circumference>90 cm if male; >80cm if female.
- Demonstrated to have inadequate control of diabetes defined as HbA1c >8.0mg/dl
Key exclusion criteria (20 listed)
- TypeII DM of more than 10 years duration.
- Weight loss of more than 9Kgs in preceding six months.
- Currently pregnant or planning to become pregnant.
- Cancer requiring treatment in the past 5 years
- Active HIV or tuberculosis
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 Roux en Y Gastric by pass surgery | Procedure or surgery | LRYGBP |
| Laparoscopic Sleeve Surgery | Procedure or surgery | LSG |
| Standard Medical Management | Other | SMM |
Primary outcome
Glycosylated Haemoglobin less than 6.5 mg/dl
Time frame: immediately after the surgery upto 2 years
The remission of Type II Diabetes Mellitus will be assessed on the basis of the Glycosylated Haemoglobin levels of the patient post surgery.. At 1 month, 3months, 12months, 24 months after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Roux en Y Gastric by pass surgery, Laparoscopic Sleeve Surgery and Standard Medical Management in people with Type 2 Diabetes Mellitus, run by Max Institute of Minimally Access, Metabolic & Bariatric Surgery at 2 sites in India.
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 8 inclusion and 20 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Glycosylated Haemoglobin less than 6.5 mg/dl (time frame: immediately after the surgery upto 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2021.