Glucose Metabolism Disorders Clinical Trial
Official title:
To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
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.
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%.
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