Moderate or Extensive Carbohydrate Reduction in Risk Patients
NCT ID: NCT03090074
Last Updated: 2019-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-03-20
2021-03-19
Brief Summary
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Randomization with regard to carbohydrate restriction (25-30 E% or \< 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.
Two-hundred patients are recruited and each patient is followed for two years.
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Detailed Description
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The participants are randomized two times (two by two factorial):
Randomization with regard to carbohydrate restriction (25-30 E% or \< 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy (ACT) or to traditional cognitive behavioral therapy. Each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. Each session will be held by the psychologists that are part of the Cityhälsan Centrum staff.
The study has \> 95% power to demonstrate 5% HbA1c (mmol/mol) difference between groups with a drop out of 25%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Moderate carbohydrate restriction and traditional support
Moderate carbohydrate restriction and traditional support with group meetings
Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Extreme low carbohydrate diet and traditional support
Extreme carbohydrate restriction and traditional support with group meetings
Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Moderate carbohydrate restriction and ACT support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Extreme carbohydrate restriction and ACT support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Interventions
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Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Linkoeping
OTHER
Responsible Party
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Fredrik H Nystrom
Professor, head of Internal Medicine, consultant in Endocrinology.
Locations
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University Hospital of Linkoping
Linköping, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Fredrik H Nystrom, MD, prof.
Role: primary
Other Identifiers
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LOWinCHIP
Identifier Type: -
Identifier Source: org_study_id
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