NCT00834626

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2012

Completed
Last Updated

September 6, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

February 1, 2009

Results QC Date

February 3, 2011

Last Update Submit

August 30, 2012

Conditions

Diabetes

Keywords

Ileal InterpositionSleeve GastrectomyType-2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Percentage of Participants Not Requiring Insulin

    1 year

  • Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents

    one year

  • Percentage of Participants Achieving Remission in Hypertension

    1 year

Study Arms (1)

Surgery group

OTHER

Interventional study of the effects of a novel metabolic procedure of Ileal Interposition with Sleeve Gastrectomy

Procedure: Ileal Interposition with Sleeve Gastrectomy

Interventions

Ileal Interposition with Sleeve GastrectomyPROCEDURE

Transposition of a segment of Ileum proximally coupled with limited /complete sleeve gastrectomy.

Also known as: Laparoscopic Ileal Interposition surgery
Surgery group

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirloskar Hospital

Hyderabad, Andhra Pradesh, 500063, India

Location

Related Publications (2)

  • 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.

    PMID: 20001679BACKGROUND

  • 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.

    PMID: 25426451DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

Non-availability of hormonal tests like Glucagon-Like Peptide-1 estimation pre- \& post-operative.

Results Point of Contact

Title
Dr. Neeraj Gupta
Organization
Kirloskar Hospital
drugale@kirloskarhospital.com
+91-40-23296241

Study Officials

  • Dr Surendra Ugale, MS

    Kirloskar Hospital, Hyderabad

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2009

First Posted

February 3, 2009

Study Start

January 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

September 6, 2012

Results First Posted

August 31, 2012

Record last verified: 2012-08

Locations

IN(1)