An interventional study of Diet regime and Type of psychological support in Glucose Metabolism Disorders, sponsored by University Hospital, Linkoeping. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Treatment
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%.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's planned enrollment of 200 is above the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →University Hospital, Linkoeping is the lead sponsor of 118 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Moderate carbohydrate restriction and traditional support with group meetings
Behavioral: Diet regime · Behavioral: Type of psychological support
Extreme carbohydrate restriction and traditional support with group meetings
Behavioral: Diet regime · Behavioral: Type of psychological support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
Behavioral: Diet regime · Behavioral: Type of psychological support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
Behavioral: Diet regime · Behavioral: Type of psychological support
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
Long-term glucose levels
HbA1c levels
Time frame: 2 years
Quality of Life
Quality of Life by questionnaires
Time frame: 2 years
Cardiovascular risk factors
Lipids, body weight, glucose, ketones
Time frame: 2 years
Plan to share: No — It is not planned to be shared
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Linkoeping