DiabetesIISGNCT00834626
Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes
A study testing Ileal Interposition with Sleeve Gastrectomy in people with Diabetes, run by Kirloskar Hospital at 1 site in India.
Trial summary
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Ileal Interposition with Sleeve Gastrectomy
- 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 2008to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration
- Body Mass Index 21 - 55 kg/m^2
- Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.
- Gives Informed Consent for the surgery
- Postmeal C peptide > 1.0 ng/mL
- Age 25 - 75 years
- Stable weight for more than 3 months
Who cannot join
- Type 1 Diabetes
- Postmeal C peptide < 1 ng/mL
- Pregnancy
- Significant nephropathy requiring dialysis
- Coexisting systemic disease
- Previous gastric or intestinal resection surgery
- Obesity due to organic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
Read the detailed description
Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.
- Conditions
- Diabetes
- Being tested
- Ileal Interposition with Sleeve Gastrectomy
- Keywords
- Ileal Interposition, Sleeve Gastrectomy, Type-2 Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileal Interposition with Sleeve GastrectomyProcedure or surgery
Also called Laparoscopic Ileal Interposition surgery
Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | Other | Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy Receives: Procedure: Ileal Interposition with Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Having Remission of Type 2 Diabetes
The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
Measured: One year
Secondary outcomes (3)
Percentage of Participants Not Requiring Insulin
After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months
Measured: 1 year
Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year
Measured: one year
Percentage of Participants Achieving Remission in Hypertension
Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication
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 posted3 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirloskar Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Surendra Ugale, MS, Principal investigator, Kirloskar Hospital, Hyderabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834626
- Sponsor's protocol ID
- KH-001
- Acronym
- IISG
- Status last verified
- Aug 2012
- First submitted
- 1 Feb 2009
- Last updated
- 6 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kumar KV, Ugale S, Gupta N, Naik V, Kumar P, Bhaskar P, Modi KD. Ileal interposition with sleeve gastrectomy for control of type 2 diabetes. Diabetes Technol Ther. 2009 Dec;11(12):785-9. doi: 10.1089/dia.2009.0070.
PubMed 20001679Ugale S, Gupta N, Modi KD, Kota SK, Satwalekar V, Naik V, Swapna M, Kumar KH. Prediction of remission after metabolic surgery using a novel scoring system in type 2 diabetes - a retrospective cohort study. J Diabetes Metab Disord. 2014 Aug 22;13(1):89. doi: 10.1186/s40200-014-0089-y. eCollection 2014.
PubMed 25426451
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study of Effects of Ileal Interposition With Sleeve Gastrectomy for Control of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00834626
- Acronym / sponsor ID
- IISG / KH-001
- Conditions
- Diabetes
- Keywords
- Ileal Interposition, Sleeve Gastrectomy, Type-2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kirloskar HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.
Detailed description
Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery group | Other | Procedure: Ileal Interposition with Sleeve GastrectomyInterventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration
- Body Mass Index 21 - 55 kg/m^2
- Poor glycemic control (HbA1c > 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.
- Gives Informed Consent for the surgery
- Postmeal C peptide > 1.0 ng/mL
Key exclusion criteria (7 listed)
- Type 1 Diabetes
- Postmeal C peptide < 1 ng/mL
- Pregnancy
- Significant nephropathy requiring dialysis
- Coexisting systemic 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 |
|---|---|---|
| Ileal Interposition with Sleeve GastrectomyAlso: Laparoscopic Ileal Interposition surgeryTransposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy. | Procedure or surgery | Surgery group |
Primary outcome
Percentage of Participants Having Remission of Type 2 Diabetes
Time frame: One year
The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped
3 secondary outcomes
Percentage of Participants Not Requiring Insulin
Time frame: 1 year
Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents
Time frame: one year
Percentage of Participants Achieving Remission in Hypertension
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20001679Kumar KV, Ugale S, Gupta N, Naik V, Kumar P, Bhaskar P, Modi KD. Ileal interposition with sleeve gastrectomy for control of type 2 diabetes. Diabetes Technol Ther. 2009 Dec;11(12):785-9. doi: 10.1089/dia.2009.0070.
- Derived from this study: PubMed 25426451Ugale S, Gupta N, Modi KD, Kota SK, Satwalekar V, Naik V, Swapna M, Kumar KH. Prediction of remission after metabolic surgery using a novel scoring system in type 2 diabetes - a retrospective cohort study. J Diabetes Metab Disord. 2014 Aug 22;13(1):89. doi: 10.1186/s40200-014-0089-y. eCollection 2014.
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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.
Dr Surendra Ugale, MS principal investigator
Kirloskar Hospital, Hyderabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ileal Interposition with Sleeve Gastrectomy in people with Diabetes, run by Kirloskar Hospital 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 7 inclusion and 7 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 6 Sep 2012. 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Having Remission of Type 2 Diabetes (time frame: One 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 NCT00834626, which also lists 2 linked publications.
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 Sep 2012.