Moderate or Extensive Carbohydrate Reduction in Risk Patients (LOWinCHIP)

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.

Study Overview

• Status: Unknown
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Behavioral: Diet regime; Behavioral: Type of psychological support

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fredrik H Nystrom, professor; Phone Number: +46 736569303; Email: fredrik.h.nystrom@gmail.com

Study Locations

• Sweden
  • Linkoping, Sweden, 58185
    • Recruiting
    • University Hospital of Linkoping
    • Contact: Fredrik H Nystrom, MD, prof.
    • Principal Investigator: Fredrik H Nystrom, MD PhD prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Anticipated): March 19, 2021
• Study Completion (Anticipated): March 19, 2021

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: LOWinCHIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not planned to be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No