NCT01197963

Brief Summary

The purpose of the study is to determine if by performing surgery we can cure Type II Diabetes. The surgical procedures:

  1. 1.a sleeve gastrectomy, cutting out a portion of the stomach, which provides restriction of caloric intake and rapid gastric emptying.
  2. 2.ileal transposition which involves repositioning a 150cm segment of the ileum into the jejunum causing improved glucose homeostasis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

3.4 years

First QC Date

September 7, 2010

Last Update Submit

June 11, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Serial Postoperative HgA1c levels

    Effectiveness of the transposition to alleviate hyperglycemia will be measured by following serial post operative HbA1c levels. The change from baseline mearusements will be used to determine the outcome. Type 2 diabetes is considered resolved if there is normalization of fasting glucose(\<110 mg/dl) normal HbA1c (\<6%) and no need for diabetic medications.

    1 month intervals for 3 months then every 3 months there after

Secondary Outcomes (1)

  • Serial Postoperative Lipid Profiles levels

    1 month for the first 3 months then every 3 months there after

Study Arms (2)

Surgical treatment

OTHER

Surgical treatment of one arm of the patient population.

Procedure: Sleeve Gastrectomy and Ileal transposition

Medically controlled group

OTHER

Managed by endocrinologists using current medical therapy such as pills, injections and life style medication.

Dietary Supplement: dietary and medical management

Interventions

Sleeve Gastrectomy and Ileal transpositionPROCEDURE

Laparoscopic sleeve gastrectomy with ileal transposition

Surgical treatment
dietary and medical managementDIETARY_SUPPLEMENT

dietary and medical routine management patients are currently following with an endocrinologist.

Medically controlled group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age- 21-55 years.
  • Body Mass Index between 25-35 kf/m2.
  • currently being treated for type 2 diabetes mellitus with oral hypoglycemic, insulin or both for the at least 3 years.
  • Documented HbA1c\>7.5% for at least 3 months.
  • Stable weight for 3 months (+/-)
  • Evidence of stable medical treatment for diabetes over the past 12 months.
  • Able to provide informed consent -Female subject agrees to participate in accepted birth control methods -

You may not qualify if:

  • Type I diabetes/juvenile onset
  • C-Peptid levels below 1.0 ng/ml
  • Previous major upper abdominal surgery
  • Pregnant or plans to become pregnant with in the next 12 months
  • Current Malignancy
  • Severe pulmonary, cardia, or renal disease
  • Eating disorders such as bulimia or binge-eating
  • Severe mental health disorders such as schizophrenia and bipolar disorder
  • Obesity due to other metabolic disorders
  • taking appetite suppressants
  • currently abusing illicit drugs,alcohol or using tobacco products
  • Unable to provide informed consent
  • Unwillingness or unable to comply with study procedures
  • any condition that deems them unsuitable for the study in the opinion of the investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas

Bellaire, Texas, 77494, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Brad E Snyder, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Surgery

Study Record Dates

First Submitted

September 7, 2010

First Posted

September 9, 2010

Study Start

September 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

US(1)