Mechanisms Behind Antidiabetic Effects by Gastric By-pass | NCT01708096

Studies
Mechanisms Behind Antidiabetic Effects by Gastric By-pass

NCT01708096

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Mar 12, 2014Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus Typ 2 and Obesity

Interventions

Modifast
Normal diet

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 9, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

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

Mar 11, 2014

Last Update Posted Date

Mar 12, 2014Estimated

Name	Class
Uppsala University 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 aim of the study is to develop new strategies in treatment of continuous increasing number of patients with type 2 diabetes by understanding how bariatric surgery cures or improves this condition.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Modifast	Active Comparator	treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,	Dietary Supplement: Modifast
Normal diet	Placebo Comparator	normal diet 2 weeks before gastric by-pass surgery	Dietary Supplement: Normal diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modifast	Dietary Supplement	2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day	Modifast

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity	Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique	12-18 month after gastric bypass

Secondary Outcomes

Measure	Description	Time Frame
Weight reduction		12-18 month after gastric bypass

Other Outcomes

Measure	Description	Time Frame
Insulin signaling and glucose transport in skeletal muscle		12-18 month after gastric by-pass

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes typ 2
18-70 years
BMI > 35 kg/m2
Treated with oral antidiabetic agents and/or insulin
laparoscopic surgery

Exclusion Criteria:

Pharmacological treatment (other then above) witch could affect glucose metabolism
open surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Thorell, Assoc Prof	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet		Stockholm	Stockholm County Council	116 91	Sweden
Uppsala University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided