Carbohydrate Content in the Diet in Type 1 Diabetes

April 25, 2023 updated by: Vastra Gotaland Region

The Effect of Carbohydrate Content in the Diet on Mean Glucose Levels in Type 1 Diabetes

The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).

The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Uddevalla, Sweden, 45180
        • NU Hospital Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 1 diabetes
  • Adults 18 years or older
  • Written Informed Consent
  • HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)

Exclusion Criteria:

  • Pregnancy or planned pregnancy for the study duration
  • Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
  • Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
  • Diabetes duration < 1 year
  • Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
  • Other investigator-determined criteria unsuitable for patient participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Moderate carbohydrate diet
A healthy diet containing 30 E % carbohydrates
Other: Moderate carbohydrate diet
30 E % carbohydrates included in the diet
Experimental: Higher carbohydrate diet
A healthy diet containing 50 E % carbohydrates
Other: Higher carbohydrate diet
50 E % carbohydrates included in the diet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The difference in mean glucose level
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference in standard deviation of glucose levels
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12
The difference in the proportion of time with high glucose levels
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12
The difference in the proportion of time with euglycaemic levels
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12
Weight
Time Frame: Week 4, week 12
The difference in weight between week 4 and week 12
Week 4, week 12
Total cholesterol
Time Frame: Week 4, week 12
The difference in total cholesterol between week 4 and week 12
Week 4, week 12
LDL cholesterol
Time Frame: Week 4, week 12
The difference in LDL cholesterol between week 4 and week 12
Week 4, week 12
HDL cholesterol
Time Frame: Week 4, week 12
The difference in HDL cholesterol between week 4 and week 12
Week 4, week 12
Triglycerides
Time Frame: Week 4, week 12
The difference in triglycerides between week 4 and week 12
Week 4, week 12
Total insulin dose
Time Frame: Week 1-4, week 9-12
The difference in total insulin dose between week 1-4 and week 9-12
Week 1-4, week 9-12
Diabetes Treatment Satisfaction Questionnaire (DTSQc) score
Time Frame: Week 12
The difference in DTSQc score at week 12
Week 12
Diabetes Treatment Satisfaction Questionnaire (DTSQs) score
Time Frame: Week 4, week 12
The difference in DTSQs scores between week 4 and week 12
Week 4, week 12
Hypoglycemia confidence score
Time Frame: Week 4, week 12
The difference in hypoglycaemia confidence scores between week 4 and week 12
Week 4, week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference in Mean Amplitude of Glycemic Excursions (MAGE)
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12
HbA1c
Time Frame: Week 4, week 12
The difference in HbA1c between week 4 and week 12
Week 4, week 12
Apolipoproteins
Time Frame: Week 4, week 12
The difference in apolipoproteins between week 4 and week 12
Week 4, week 12
The difference in the proportion of time with low glucose levels
Time Frame: Week 3-4, week 11-12
Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12
Week 3-4, week 11-12
Ketones
Time Frame: Week 1-4, week 9-12
The difference in ketone levels between week 1-4 and week 9-12
Week 1-4, week 9-12
Ketoacidosis
Time Frame: Week 1-4, week 9-12
Occurence of ketoacidosis during the study period and differences between week 1-4 and week 9-12
Week 1-4, week 9-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vastra Gotaland Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcus Lind, PhD, NU Hospital Organization/University of Gothenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Carbohydrate study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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