Clinical trial NCT03090074: Moderate or Extensive Carbohydrate Reduction in Risk Patients
Official title: To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glucose Metabolism Disorders
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

Eligibility criteria: Inclusion Criteria:

* Diabetes without insulin. Patients at high risk for developing diabetes.

Exclusion Criteria:

* Severe kidney failure. Insulin therapy. Inability to understand instructions.

Primary outcomes:
measure: Long-term glucose levels
timeFrame: 2 years
Secondary outcomes:
measure: Quality of Life
timeFrame: 2 years
measure: Cardiovascular risk factors
timeFrame: 2 years
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital of Linkoping
Study officials:
References: