Trial Outcomes & Findings for Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes (NCT NCT00834626)

NCT ID: NCT00834626

Last Updated: 2012-09-06

Results Overview

The number of patients who 1 year after surgery, have a normal glycated hemoglobin (HbA1c) less than 6.5% and all medication is stopped

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: One year
• Results posted on: 2012-09-06

Participant Flow

Recruitment started in Jan 2008, at Kirloskar Hospital. Recruitment completed in May 2010.

Participant milestones

Measure	Surgery Group Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
Overall Study STARTED	30
Overall Study 1 Year Follow-up	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Baseline characteristics by cohort

Measure	Surgery Group n=30 Participants Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	47.233 years STANDARD_DEVIATION 9.605 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment India	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Percentage of Participants Not Requiring Insulin n=30 Participants Percentage of participants not requiring Insulin assessed at 1 year post-surgery
Percentage of Participants Having Remission of Type 2 Diabetes	76.66 Percentage of Participants

SECONDARY outcome

Timeframe: 1 year

After this Metabolic surgery, usually no Insulin is required by patient after 1 month, and definitely not after 3 months

Outcome measures

Measure	Percentage of Participants Not Requiring Insulin n=30 Participants Percentage of participants not requiring Insulin assessed at 1 year post-surgery
Percentage of Participants Not Requiring Insulin	90 Percentage of Participants

SECONDARY outcome

Timeframe: one year

Percentage of participants showing decrease in requirement of oral anti-diabetic agents taken earlier for treatment of Type-2 Diabetes, assessed at one year

Outcome measures

Measure	Percentage of Participants Not Requiring Insulin n=30 Participants Percentage of participants not requiring Insulin assessed at 1 year post-surgery
Percentage of Participants Showing Decrease in Requirement of Oral Anti-diabetic Agents	93 Percentage of Participants

SECONDARY outcome

Timeframe: 1 year

Percentage of participants achieving remission in hypertension, that is blood pressure less than 130/80 mm Hg without any anti-hypertensive medication

Outcome measures

Measure	Percentage of Participants Not Requiring Insulin n=30 Participants Percentage of participants not requiring Insulin assessed at 1 year post-surgery
Percentage of Participants Achieving Remission in Hypertension	90 Percentage of Participants

Adverse Events

Surgery Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neeraj Gupta

Kirloskar Hospital

Phone: +91-40-23296241

Email: drugale@kirloskarhospital.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place