Moderate or Extensive Carbohydrate Reduction in Risk Patients

NCT03090074 | Unknown

• 1 other identifier: LOWinCHIP
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Glucose Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Long-term glucose levels

  HbA1c levels

  2 years

Secondary Outcomes (2)

• Quality of Life

  2 years

• Cardiovascular risk factors

  2 years

Study Arms (4)

Moderate carbohydrate restriction and traditional support

ACTIVE COMPARATOR

Moderate carbohydrate restriction and traditional support with group meetings

Behavioral: Diet regime; Behavioral: Type of psychological support

Extreme low carbohydrate diet and traditional support

ACTIVE COMPARATOR

Extreme carbohydrate restriction and traditional support with group meetings

Behavioral: Diet regime; Behavioral: Type of psychological support

Moderate carbohydrate restriction and ACT support

ACTIVE COMPARATOR

Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy

Behavioral: Diet regime; Behavioral: Type of psychological support

Extreme carbohydrate restriction and ACT support

ACTIVE COMPARATOR

Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy

Behavioral: Diet regime; Behavioral: Type of psychological support

Interventions

Diet regime BEHAVIORAL

Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.

Extreme carbohydrate restriction and ACT support; Extreme low carbohydrate diet and traditional support; Moderate carbohydrate restriction and ACT support; Moderate carbohydrate restriction and traditional support

Type of psychological support BEHAVIORAL

Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy

Extreme carbohydrate restriction and ACT support; Extreme low carbohydrate diet and traditional support; Moderate carbohydrate restriction and ACT support; Moderate carbohydrate restriction and traditional support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University Hospital of Linkoping

Linköping, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Fredrik H Nystrom, professor

CONTACT

736569303; fredrik.h.nystrom@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of Internal Medicine, consultant in Endocrinology.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: March 20, 2017
• Primary Completion: March 19, 2021
• Study Completion: March 19, 2021
• Last Updated: October 15, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)