Moderate or Extensive Carbohydrate Reduction in Risk Patients

Study Overview
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Brief Summary
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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
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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%.

Official Title
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To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support

Conditions
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Glucose Metabolism Disorders

Intervention / Treatment
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* Behavioral: Diet regime
* Behavioral: Type of psychological support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes without insulin. Patients at high risk for developing diabetes. Exclusion Criteria: Severe kidney failure. Insulin therapy. Inability to understand instructions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moderate carbohydrate restriction and traditional support<br>Moderate carbohydrate restriction and traditional support with group meetings | Behavioral: Diet regime<br>* Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.<br>Behavioral: Type of psychological support<br>* Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy<br>|
| Active Comparator: Extreme low carbohydrate diet and traditional support<br>Extreme carbohydrate restriction and traditional support with group meetings | Behavioral: Diet regime<br>* Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.<br>Behavioral: Type of psychological support<br>* Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy<br>|
| Active Comparator: Moderate carbohydrate restriction and ACT support<br>Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy | Behavioral: Diet regime<br>* Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.<br>Behavioral: Type of psychological support<br>* Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy<br>|
| Active Comparator: Extreme carbohydrate restriction and ACT support<br>Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy | Behavioral: Diet regime<br>* Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.<br>Behavioral: Type of psychological support<br>* Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term glucose levels | HbA1c levels | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life by questionnaires | 2 years | 
| Cardiovascular risk factors | Lipids, body weight, glucose, ketones | 2 years |