Moderate or Extensive Carbohydrate Reduction in Risk Patients
- Conditions
- Glucose Metabolism Disorders
- Interventions
- Behavioral: Diet regimeBehavioral: Type of psychological support
- Registration Number
- NCT03090074
- Lead Sponsor
- University Hospital, Linkoeping
- Brief Summary
Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:
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.
- Detailed Description
The organizers will recruit 200 patients in the study "To lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (LOWinCHIP) at the primary care health center "Cithyhälsan Centrum" in Norrköping. Each patient will be followed for 2 years. Patients are eligible if they have are above 18 years of age and have a BMI above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) Patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. Finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. Patients must not have insulin therapy or severe kidney failure (GFR\< 30). They can also not have severe physical restrictions for activity and they must not have difficulties with understanding written Swedish texts.
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%.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Diabetes without insulin. Patients at high risk for developing diabetes.
- Severe kidney failure. Insulin therapy. Inability to understand instructions.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Moderate carbohydrate restriction and traditional support Diet regime Moderate carbohydrate restriction and traditional support with group meetings Extreme carbohydrate restriction and ACT support Type of psychological support Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy Extreme low carbohydrate diet and traditional support Diet regime Extreme carbohydrate restriction and traditional support with group meetings Moderate carbohydrate restriction and traditional support Type of psychological support Moderate carbohydrate restriction and traditional support with group meetings Moderate carbohydrate restriction and ACT support Diet regime Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy Extreme low carbohydrate diet and traditional support Type of psychological support Extreme carbohydrate restriction and traditional support with group meetings Moderate carbohydrate restriction and ACT support Type of psychological support Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy Extreme carbohydrate restriction and ACT support Diet regime Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
- Primary Outcome Measures
Name Time Method Long-term glucose levels 2 years HbA1c levels
- Secondary Outcome Measures
Name Time Method Cardiovascular risk factors 2 years Lipids, body weight, glucose, ketones
Quality of Life 2 years Quality of Life by questionnaires
Trial Locations
- Locations (1)
University Hospital of Linkoping
🇸🇪Linkoping, Sweden