Lifestyle Intervention in Obesity, Effect on Diabetes | NCT00466362

Studies
Lifestyle Intervention in Obesity, Effect on Diabetes

NCT00466362

Sponsor

Tor-Ivar Karlsen

Status

Withdrawn

Last Update Posted

Aug 28, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

The Evje Model

Countries

Norway

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 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment problems

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Dec 2008Estimated

First Submitted Date

Apr 25, 2007

First Submission Date that Met QC Criteria

Apr 25, 2007

First Posted Date

Apr 27, 2007Estimated

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 26, 2024

Last Update Posted Date

Aug 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

There are evidence from numerous studies on effect of lifestyle intervention in morbidly obese patients with type 2 diabetes. This study examines the effect of the "Evje-model" on type 2 diabetes.

The "Evje-model" is a combined 12 months model, consisting of repeated stays in a specialist centre, telephone follow-up at home, home groups, self monitoring and close contact with the patients' local physician.

Detailed Description

There will be done QOL-measures, blood- and urine analysis, weight, waist- and hip measurement, blood pressure and VO2-max measurement at baseline, after 6 months and after 12 months.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
The Evje Model	Behavioral	Lifestyle intervention

Measure	Description	Time Frame
Health related quality of life		2007

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with BMI > 35 with diagnosed type 2 diabetes
Referred to Lifestyle Intervention from a public hospital

Exclusion Criteria:

Pregnancy
Active major psychiatric disease(s)
Active and serious eating disorder
Drug- and/or alcohol dependency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

67 Years

Standard Ages

AdultOlder Adult

Study Population

Morbidly obese patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tom B Schulz, Dr. Med.	Evjeklinikken	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Evjeklinikken AS		Evje Og Hornnes	Evjemoen	4735	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D003920	Diabetes Mellitus
D001835	Body Weight

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided