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Moderate or Extensive Carbohydrate Reduction in Risk Patients (LOWinCHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03090074
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Fredrik H Nystrom, University Hospital, Linkoeping

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.


Condition or disease Intervention/treatment Phase
Glucose Metabolism Disorders Behavioral: Diet regime Behavioral: Type of psychological support Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 19, 2021
Estimated Study Completion Date : March 19, 2021

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




Primary Outcome Measures :
  1. Long-term glucose levels [ Time Frame: 2 years ]
    HbA1c levels


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 years ]
    Quality of Life by questionnaires

  2. Cardiovascular risk factors [ Time Frame: 2 years ]
    Lipids, body weight, glucose, ketones



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090074


Contacts
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Contact: Fredrik H Nystrom, professor 736569303 ext +46 fredrik.h.nystrom@gmail.com

Locations
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Sweden
University Hospital of Linkoping Recruiting
Linkoping, Sweden, 58185
Contact: Fredrik H Nystrom, MD, prof.         
Principal Investigator: Fredrik H Nystrom, MD PhD prof         
Sponsors and Collaborators
University Hospital, Linkoeping

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Responsible Party: Fredrik H Nystrom, Professor, head of Internal Medicine, consultant in Endocrinology., University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT03090074    
Other Study ID Numbers: LOWinCHIP
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It is not planned to be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders