Type 2 DiabetesNCT00466362
Lifestyle Intervention in Obesity, Effect on Diabetes
An observational study of Type 2 Diabetes, run by Tor-Ivar Karlsen at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- The Evje Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients
Who may be able to join
- All patients with BMI > 35 with diagnosed type 2 diabetes
- Referred to Lifestyle Intervention from a public hospital
Who cannot join
- Pregnancy
- Active major psychiatric disease(s)
- Active and serious eating disorder
- Drug- and/or alcohol dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- The Evje Model
- Keywords
- Obesity, Diabetes, Weight, Lifestyle, Follow up
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Diabetes Mellitus, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Evje ModelBehavioural
Lifestyle intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured: 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionDec 2008 (estimated)
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tor-Ivar Karlsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor-Ivar Karlsen, Evjeklinikken
- Investigators
- Tom B Schulz, Dr. Med., Principal investigator, Evjeklinikken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466362
- Sponsor's protocol ID
- EK0702
- Status last verified
- Aug 2024
- First submitted
- 25 Apr 2007
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Observational Study on Effects of Lifestyle Intervention in Morbidly Obese Persons With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00466362
- Acronym / sponsor ID
- EK0702
- Conditions
- Type 2 Diabetes
- Keywords
- Obesity, Diabetes, Weight, Lifestyle, Follow up
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tor-Ivar KarlsenUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients
Key inclusion criteria (2 listed)
- All patients with BMI > 35 with diagnosed type 2 diabetes
- Referred to Lifestyle Intervention from a public hospital
Key exclusion criteria (4 listed)
- Pregnancy
- Active major psychiatric disease(s)
- Active and serious eating disorder
- Drug- and/or alcohol dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Evje ModelLifestyle intervention | Behavioural | – |
Primary outcome
Health related quality of life
Time frame: 2007
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom B Schulz, Dr. Med. principal investigator
Evjeklinikken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Tor-Ivar Karlsen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: 2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.