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Clinical Trials/NCT00466362
NCT00466362
Withdrawn
Not Applicable

One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.

Tor-Ivar Karlsen1 site in 1 countryApril 2007
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Tor-Ivar Karlsen
Locations
1
Primary Endpoint
Health related quality of life
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
December 2008
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Tor-Ivar Karlsen
Responsible Party
Sponsor Investigator
Principal Investigator

Tor-Ivar Karlsen

RN

Evjeklinikken

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

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: 2007

Study Sites (1)

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