Moderate or Extensive Carbohydrate Reduction in Risk Patients

Glucose Metabolism Disorders Clinical Trial

— LOWinCHIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090074
• Other study ID #: LOWinCHIP
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: March 19, 2021

Study information

• Verified date: October 2019
• Source: University Hospital, Linkoeping
• Contact: Fredrik H Nystrom, professor
• Phone: 736569303
• Email: fredrik.h.nystrom[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 19, 2021
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Behavioral:
• Diet regime
Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
• Type of psychological support
Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy

Locations

Country	Name	City	State
Sweden	University Hospital of Linkoping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term glucose levels	HbA1c levels	2 years
Secondary	Quality of Life	Quality of Life by questionnaires	2 years
Secondary	Cardiovascular risk factors	Lipids, body weight, glucose, ketones	2 years