Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 9:28 PM
Study NCT ID:
NCT00999050
Status:
UNKNOWN
Last Update Posted:
2011-01-04
First Post:
2009-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus With Body Mass Index (BMI) < 35
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: a Pilot Prospective Study in Overweight and Mildly Obese Subjects
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the effect of Roux-en-y gastric bypass (RYGB) in controlling diabetes in subjects with mild obesity (BMI 26-35). The primary endpoint will be the reduction of HbA1c (\< 7%), a standard measure of diabetes control; the secondary endpoints will be changes blood sugar , vitamin levels, insulin, c-peptide, and lipids levels, as well as retinal eye examinations, urinalysis to assess kidney function, carotid ultrasound as a marker of cardiovascular function, and alterations in diabetic medications. Fifty subjects with medically documented type 2 Diabetes Mellitus (T2DM) with BMIs between 26 and 35 will undergo standard laparoscopic RYGB. Prior and after surgery, the subjects will undergo a clinical evaluation in regard to the primary and secondary endpoints listed. The pre-surgery evaluation is directed toward establishing the existence of diabetes related complications prior to surgery. After surgery subjects will be closely monitored for complications and required changes in their diabetes management. Repeat assessments will be made at 1, 3, 6, and 12 months and at two years.
Detailed Description:
The primary endpoint will be the reduction of HbA1c and secondary endpoints will be multiple associated parameters as listed below. A group of 50 subjects with medically documented T2DM and BMI of 26-35 will undergo standard laparoscopic RYGB. Prior to surgery, the subjects will undergo the standard pre-operative work up required for conventional bariatric surgery. This includes full history and physical exam, medical/cardiac clearances as needed, nutrition consultation and a gastrointestinal consultation for upper endoscopy. After thorough explanation an approved informed consent will be signed. Baseline parameters, as listed below, will be measured for each subject to identify possible complications of diabetes prior to the surgical intervention..
After surgery perioperative complications will be monitored and required modifications of diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is consistent with standard clinical practice guidelines. Data analysis will be ongoing to observe the effects of the surgical intervention on glucose homeostasis.
* Baseline parameters
* History and Physical Exam
* Weight/BMI/ body composition with the Tanita 310.
* Waist Circumference
* Blood Pressure
* CBC
* HbA1c
* Fasting glucose
* Vitamin B6, B12, Folate,and Iron status
* Lipid Profile -total cholesterol, HDL, LDL, triglyceride
* Fasting Insulin and C-peptide
* Stimulated C-peptide
* EKG
* Retinal exam
* Urinalysis (assess for proteinuria and microalbuminuria)
* Comprehensive foot exam
* Medications and dosage
* Quality of Life Score (SF-36)
* Carotid ultrasound (intima-media thickness)
Follow-up:
4 Weeks:
* Physical Examination, wound check, Body weight, BMI,
* Glucose Diary (pre and postprandial glucose levels as required)
* Insulin and C-peptide
* Lipid profile
* Medication use
3 Months, 6 months,
Same as above plus:
* HbA1c
* Vitamin levels and iron status
* Retinal exam
* Annually the baseline measurements will be repeated
After surgery perioperative complications will be monitored and required modifications of diabetes management advised. Followed up measurements at 1, 3, 6, 12, and 24 months is consistent with standard clinical practice guidelines. Data analysis will be ongoing to observe the effects of the surgical intervention on glucose homeostasis.
* Baseline parameters
* History and Physical Exam
* Weight/BMI/ body composition with the Tanita 310.
* Waist Circumference
* Blood Pressure
* CBC
* HbA1c
* Fasting glucose
* Vitamin B6, B12, Folate,and Iron status
* Lipid Profile -total cholesterol, HDL, LDL, triglyceride
* Fasting Insulin and C-peptide
* Stimulated C-peptide
* EKG
* Retinal exam
* Urinalysis (assess for proteinuria and microalbuminuria)
* Comprehensive foot exam
* Medications and dosage
* Quality of Life Score (SF-36)
* Carotid ultrasound (intima-media thickness)
Follow-up:
4 Weeks:
* Physical Examination, wound check, Body weight, BMI,
* Glucose Diary (pre and postprandial glucose levels as required)
* Insulin and C-peptide
* Lipid profile
* Medication use
3 Months, 6 months,
Same as above plus:
* HbA1c
* Vitamin levels and iron status
* Retinal exam
* Annually the baseline measurements will be repeated
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: