Weight LossPhase 3NCT04325581
Laparocopic Sleeve Gastrectomy With or Without Liraglutide in Obese Patients
A Phase 3 study testing Liraglutide 6 MG/ML in people with Weight Loss, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Liraglutide 6 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 2018
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with obesity who have elected to undergo bariatric surgery
- Body mass index greater than 27.5kg/mt2
- Ability and willingness to co-operate with follow up.
Who cannot join
- Decompensated liver disease ( child-turcotte pugh score >7)
- Impaired renal function, defined as eGFR< 45 ml/min/m2
- Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV)
- Recurrent major hypoglycemic episodes
- Use of drugs like systemic corticosteroids, thiazolidinediones, DPPIV inhibitors
- Pregnancy or lactation
Show all 18Show fewer
- History of pancreatitis or pancreatic cancer
- History of medullary thyroid cancer
- Family history of medullary thyroid cancer
- Contraindications to liraglutide or any of its excipients
- Hypersensitivity to liraglutide or similar drugs
- Patients currently using GLP-1 analogs
- Suspected or known abuse of alcohol
- Presence of secondary cause of obesity.
- Presence of an eating disorder or other psychiatric disorder.
- Prior gastric surgery.
- Unfit for surgery due to severe cardiac, pulmonary diseases or due to any reason.
- Contraindications to MRI scanning
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients
Investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese patients in a placebo controlled design.
Read the detailed description
Various studies have shown that bariatric surgery is associated with significant durable weight loss with associated improvement in obesity related comorbidities and quality of life. The degree of effect on obesity related comorbidities depends on the bariatric surgery approach, typically classified as restrictive and/or malabsorptive effect. Data from International Federation for the Surgery of Obesity and Metabolic Diseases states that most common surgical procedures being performed are Roux-en-Y gastric bypass (45%), sleeve gastrectomy(37%), adjustable gastric banding(10%) and biliopancreatic division with or without duodenal switch(2.5%)5. . LSG is technically a simpler procedure compared to RYGB with lesser operative and long term nutritional complications. The mechanism for weight loss in laparoscopic sleeve gastrectomy is gastric restriction and possible changes in gut hormones resulting from higher level of GLP-1, and lower levels of ghrelin, as a consequence of resection of gastric fundus.
Therefore,investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese participants in a placebo controlled design.
- Conditions
- Weight Loss
- Being tested
- Liraglutide 6 MG/ML, Placebos
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide 6 MG/MLDrug
Also called Calorie restricted diet
Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
PlacebosDrug
Also called Calorie restricted diet
Normal Saline SC daily
| Study group | Role | What they receive |
|---|---|---|
| Post LSG with Liraglutude | Experimental | Liraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day. Receives: Drug: Liraglutide 6 MG/ML |
| Post LSG without Liraglutide | Placebo comparator | Normal Saline in equivalent per day subcutaneously once a day Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incretin change
Changes in GLP-1 levels during 2hour OGTT
Measured: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Changes in indices of insulin resistance
HOMA-IR calculated from fasting insulin and fasting glucose
Measured: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Change in pancreatic steatosis
Change in pancreatic steatosis would be determined using NUTS ACORN NMR software
Measured: baseline and 6months after laparoscopic sleeve gastrectomy
Secondary outcomes (1)
body weight
The change in body weight
Measured: baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Aug 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional , Placebo Control
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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, Ashu Rastogi, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325581
- Sponsor's protocol ID
- pgi123
- Status last verified
- Mar 2020
- First submitted
- 20 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy and Liraglutide on Glucose Homeostasis and Intrapancreatic Fat in Obese Patients
- ClinicalTrials.gov ID
- NCT04325581
- Acronym / sponsor ID
- pgi123
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Mar 2020 (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.
Investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese patients in a placebo controlled design.
Detailed description
Various studies have shown that bariatric surgery is associated with significant durable weight loss with associated improvement in obesity related comorbidities and quality of life. The degree of effect on obesity related comorbidities depends on the bariatric surgery approach, typically classified as restrictive and/or malabsorptive effect. Data from International Federation for the Surgery of Obesity and Metabolic Diseases states that most common surgical procedures being performed are Roux-en-Y gastric bypass (45%), sleeve gastrectomy(37%), adjustable gastric banding(10%) and biliopancreatic division with or without duodenal switch(2.5%)5. . LSG is technically a simpler procedure compared to RYGB with lesser operative and long term nutritional complications. The mechanism for weight loss in laparoscopic sleeve gastrectomy is gastric restriction and possible changes in gut hormones resulting from higher level of GLP-1, and lower levels of ghrelin, as a consequence of resection of gastric fundus.
Therefore,investigators postulate that the metabolic effects of LSG would be augmented with the use of liraglutide leading to additional excess weight loss, improved glucose homeostasis, decreased intrapancreatic and intrahepatic fat than either of them individually. However there are no studies till date which have evaluated the combined effects of two modalities of weight loss on the above mentioned parameters. This study plans to compare the effects of liraglutide in post- LSG obese participants in a placebo controlled design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional , Placebo Control
| Arm | Type | Receives |
|---|---|---|
| Post LSG with Liraglutude | Experimental | Drug: Liraglutide 6 MG/MLLiraglutide in incremental dose upto maximum of 1.8 mg per day subcutaneously once a day. |
| Post LSG without Liraglutide | Placebo comparator | Drug: PlacebosNormal Saline in equivalent per day subcutaneously once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects diagnosed with obesity who have elected to undergo bariatric surgery
- Body mass index greater than 27.5kg/mt2
- Ability and willingness to co-operate with follow up.
Key exclusion criteria (18 listed)
- Decompensated liver disease ( child-turcotte pugh score >7)
- Impaired renal function, defined as eGFR< 45 ml/min/m2
- Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (New York Heart Association (NYHA) class III and IV)
- Recurrent major hypoglycemic episodes
- Use of drugs like systemic corticosteroids, thiazolidinediones, DPPIV inhibitors
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 |
|---|---|---|
| Liraglutide 6 MG/MLAlso: Calorie restricted dietLiraglutide in incremental dose upto maximum of 1.8 mg per day SC daily | Drug | Post LSG with Liraglutude |
| PlacebosAlso: Calorie restricted dietNormal Saline SC daily | Drug | Post LSG without Liraglutide |
Primary outcome
Incretin change
Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
Changes in GLP-1 levels during 2hour OGTT
Changes in indices of insulin resistance
Time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy
HOMA-IR calculated from fasting insulin and fasting glucose
Change in pancreatic steatosis
Time frame: baseline and 6months after laparoscopic sleeve gastrectomy
Change in pancreatic steatosis would be determined using NUTS ACORN NMR software
1 secondary outcome
body weight
Time frame: baseline and 6 weeks, 12weeks, 18weeks and 24weeks after surgery
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 27 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liraglutide 6 MG/ML in people with Weight Loss, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 3 inclusion and 18 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 27 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incretin change (time frame: baseline and at 6weeks and 6months after laparoscopic sleeve gastrectomy). The study lists 3 primary outcomes in all. 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 27 Mar 2020.