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Clinical Trials/NCT00466362
NCT00466362WithdrawnNot Applicable

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

Tor-Ivar Karlsen1 site in 1 countryStarted: April 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Health related quality of life

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 67 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Tor-Ivar Karlsen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Tor-Ivar Karlsen

RN

Evjeklinikken

Study Sites (1)

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