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NCT00466362 Clinical Trial

Lifestyle Intervention in Obesity, Effect on Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00466362
Other study ID # EK0702
Secondary ID
Status Recruiting
Phase N/A
First received April 25, 2007
Last updated May 22, 2007
Start date April 2007
Est. completion date December 2008

Study information
Verified date May 2007
Source Evjeklinikken
Contact Tor I Karlsen, RN
Phone 0047 900 60 536
Email tik@evjeklinikken.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 67 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Behavioral:
• The Evje Model

Locations
Country Name City State
Norway Evjeklinikken AS Evje og Hornnes Evjemoen

Sponsors (1)
Lead Sponsor Collaborator
Evjeklinikken

Country where clinical trial is conducted

Norway, 

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