Diabetes MellitusNCT01429506
Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
A study testing Sleeve gastrectomy and Intensive medical management in people with Diabetes Mellitus and Obesity, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- Sleeve gastrectomy and Intensive medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2011to Aug 2012
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetics with
- BMI ≥ 27.5 kg/m2
- HbA1c 7-10%
- Age 20-70 years
Who cannot join
- Prior gastric surgery
- Pregnancy and lactation
- renal disease (GFR < 60 ml/min)
- Pancreatitis
- Symptomatic gallstone disease
- Active malignancy
Show all 9Show fewer
- Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)
- Severe psychiatric illness
- Allergic reaction to exenatide
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.
Read the detailed description
Intensive medical management will include
- VLCD
- Physical activity
- Exenatide
- Metformin
- Insulin detemir
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- Sleeve gastrectomy, Intensive medical management
- Keywords
- Sleeve gastrectomy, Intensive medical management
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Also called Bariatric surgery, Laparoscopic sleeve gastrectomy
Sleeve gastrectomy
Intensive medical managementDrug
Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy | Active comparator | Will undergo laparoscopic sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
| Intensive medical management | Active comparator | Will receive VLCD, exenatide, metformin, insulin detemir Receives: Drug: Intensive medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
weight loss at 6 months after the start of intervention
Measured: 6 months
Secondary outcomes (1)
glycemic control
HbA1c and glucose profile
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Bhansali, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Anil Bhansali, DM, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429506
- Sponsor's protocol ID
- 922861
- Status last verified
- Oct 2015
- First submitted
- 4 Sep 2011
- Last updated
- 26 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01429506
- Acronym / sponsor ID
- 922861
- Conditions
- Diabetes Mellitus, Obesity
- Keywords
- Sleeve gastrectomy, Intensive medical management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Sep 2011 (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.
In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.
Detailed description
Intensive medical management will include
- VLCD
- Physical activity
- Exenatide
- Metformin
- Insulin detemir
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy | Active comparator | Procedure: Sleeve gastrectomyWill undergo laparoscopic sleeve gastrectomy |
| Intensive medical management | Active comparator | Drug: Intensive medical managementWill receive VLCD, exenatide, metformin, insulin detemir |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 Diabetics with
- BMI ≥ 27.5 kg/m2
- HbA1c 7-10%
- Age 20-70 years
Key exclusion criteria (9 listed)
- Prior gastric surgery
- Pregnancy and lactation
- renal disease (GFR < 60 ml/min)
- Pancreatitis
- Symptomatic gallstone disease
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 |
|---|---|---|
| Sleeve gastrectomyAlso: Bariatric surgery, Laparoscopic sleeve gastrectomySleeve gastrectomy | Procedure or surgery | Sleeve gastrectomy |
| Intensive medical managementExenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet | Drug | Intensive medical management |
Primary outcome
weight loss
Time frame: 6 months
weight loss at 6 months after the start of intervention
1 secondary outcome
glycemic control
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2015.
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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.
Anil Bhansali, DM, MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy and Intensive medical management in people with Diabetes Mellitus and Obesity, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
weight loss (time frame: 6 months). 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 26 Oct 2015.