Mechanisms of Diabetes Control After Weight Loss Surgery,... | NCT01930448

Studies
Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

NCT01930448

Sponsor

St. Luke's-Roosevelt Hospital Center

Status

Withdrawn

Last Update Posted

Sep 11, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Gastric Bypass Surgery
Gastric Banding
Type 2 Diabetes

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI relocated to another Institution

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Aug 20, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2015

Last Update Posted Date

Sep 11, 2015Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Detailed Description

All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gastric bypass		Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
gastric banding		surgical group of obese patients with type 2 diabetes undergoing gastric banding

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Incretin Effect	Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)	Before surgery, 1, 12, and 24 months post

Secondary Outcomes

Measure	Description	Time Frame
Change in Body Composition	Body composition measurements to determine body volume, size, and fat	Before surgery, 12, and 24 months post

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blandine Laferrere, MD	New York Obesity Nutrition Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research Center		New York	New York	10025	United States

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided