Changes in Incretins Response and Glycemic Control After... | NCT01820273

Studies
Changes in Incretins Response and Glycemic Control After Gastric Bypass Surgery in Type 2 Diabetic Patients Versus Healthy

NCT01820273

Sponsor

Lund University

Status

Withdrawn

Last Update Posted

Aug 7, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Type 2 Diabetes
Obesity

Interventions

Not provided

Countries

Sweden

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study no longer at LU.

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

May 1, 2016Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Mar 25, 2013

First Submission Date that Met QC Criteria

Mar 27, 2013

First Posted Date

Mar 28, 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

Aug 5, 2019

Last Update Posted Date

Aug 7, 2019Actual

Name	Class
Kalmar County Hospital	OTHER

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

The purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. The study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. Also aiming for recording changes in the earliest postoperative phase.

Detailed Description

Not provided

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

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in incretines in the bariatric patient	standardized meals prior to pre op diet, day before surgery, first day after surgery and 6 weeks after surgery.	2 months prior to surgery - 6 weeks post surgery

Secondary Outcomes

Measure	Description	Time Frame
Diabetes control	resolution of t2D as early as first day after surgery	6 weeks post surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of type 2 diabetes
obesity BMI >35

Exclusion Criteria:

prior bariatric surgery

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

female obese (BMI>35)patients accepted for bariatric surgery (lap gastric bypass). 10 patients with type 2 diabetes(T2D) 6 10 matched controls without T2D.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nils Wierup	Lunds Universitet, Clinical researchcenter	Study Director
Johan Berggren, MD	Lunds Universitet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kalmar County Hospital		Kalmar		39185	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity

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