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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery group | Other | Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ileal Interposition with Sleeve Gastrectomy | Procedure | Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Surendra Ugale, MS | Kirloskar Hospital, Hyderabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirloskar Hospital | Hyderabad | Andhra Pradesh | 500063 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20001679 | Background | 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. | |
| 25426451 | Derived | Ugale 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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Recruitment started in Jan 2008, at Kirloskar Hospital. Recruitment completed in May 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery Group | Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgery Group | Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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 | Posted | Aug 2011 | Number | Percentage of Participants | 1 year |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery Group | Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes |
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Non-availability of hormonal tests like Glucagon-Like Peptide-1 estimation pre- & post-operative.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neeraj Gupta | Kirloskar Hospital | +91-40-23296241 | drugale@kirloskarhospital.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year |
| 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 | 1 year |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Posted | Aug 2011 | Number | Percentage of Participants | one year |
|
|
|
| Primary | 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 | Posted | Aug 2011 | Number | Percentage of Participants | One year |
|
|
|
| Secondary | 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 | Posted | Number | Percentage of Participants | 1 year |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
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