NCT03400618

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

4.8 years

First QC Date

January 5, 2018

Last Update Submit

April 25, 2023

Conditions

Diabetes Mellitus, Type 1

Keywords

CarbohydratesDietDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • The difference in mean glucose level

    Measured by continuous glucose monitoring (CGM) between week 3-4 and week 11-12

    Week 3-4, week 11-12

Secondary Outcomes (12)

  • The difference in standard deviation of glucose levels

    Week 3-4, week 11-12

  • The difference in the proportion of time with high glucose levels

    Week 3-4, week 11-12

  • The difference in the proportion of time with euglycaemic levels

    Week 3-4, week 11-12

  • Weight

    Week 4, week 12

  • Total cholesterol

    Week 4, week 12

  • +7 more secondary outcomes

Other Outcomes (6)

  • The difference in Mean Amplitude of Glycemic Excursions (MAGE)

    Week 3-4, week 11-12

  • HbA1c

    Week 4, week 12

  • Apolipoproteins

    Week 4, week 12

  • +3 more other outcomes

Study Arms (2)

Moderate carbohydrate diet

EXPERIMENTAL

A healthy diet containing 30 E % carbohydrates

Other: Moderate carbohydrate diet

Higher carbohydrate diet

EXPERIMENTAL

A healthy diet containing 50 E % carbohydrates

Other: Higher carbohydrate diet

Interventions

Moderate carbohydrate dietOTHER

30 E % carbohydrates included in the diet

Moderate carbohydrate diet
Higher carbohydrate dietOTHER

50 E % carbohydrates included in the diet

Higher carbohydrate diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnancy or planned pregnancy for the study duration
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NU Hospital Organization

Uddevalla, 45180, Sweden

Location

Related Publications (1)

  • Sterner Isaksson S, Olafsdottir AF, Lind M. Design of a randomized cross-over study evaluating effects of carbohydrate intake on glycemic control in persons with type 1 diabetes. Front Nutr. 2023 Mar 13;10:1114317. doi: 10.3389/fnut.2023.1114317. eCollection 2023.

    PMID: 36992911DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marcus Lind, PhD

    NU Hospital Organization/University of Gothenburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 17, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)