NCT04343131

Brief Summary

The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

April 9, 2020

Last Update Submit

April 10, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1GlycemiaContinuous glucose monitoringDiet

Outcome Measures

Primary Outcomes (1)

  • Percentage of time spent with glucose levels between 70-140 mg/dl

    Percentage of time spent with glucose levels between 70-140 mg/dl

    7 days

Study Arms (3)

Mediterranean diet

ACTIVE COMPARATOR

Mediterranean diet for 7 days

Behavioral: Dietary intervention

Low-carb/high protein diet

ACTIVE COMPARATOR

Low-carb/high protein diet for 7 days

Behavioral: Dietary intervention

Reference diet

ACTIVE COMPARATOR

Reference diet for 7 days

Behavioral: Dietary intervention

Interventions

Dietary interventionBEHAVIORAL

Crossover dietary manipulation using three different types of diet for 7 days each

Low-carb/high protein dietMediterranean dietReference diet

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with T1D receiving MDI therapy
  • Sufficient education and knowledge on carbohydrate counting
  • Motivation to follow a specific dietary schedule
  • Frequent (7 times a-day) self-monitoring of blood glucose (SMBG)
  • Willingness to wear a CGM system

You may not qualify if:

  • HbA1c \>8%
  • Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Alexandros Kokkinos, MD, PhD

    Medical School, National and Kapodistrian University of Athens, Laiko Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

November 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share