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Completed

NCT Number: NCT04343131

Different Dietary Interventions and Glycemia in T1DM

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).

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Key information

About this study

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

Three different isocaloric diets, namely, a Mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with T1D for three separate weeks, in a random order, and with 7-day washout periods in-between. Glycemia was assessed during each 7-day period using a continuous glucose monitoring system. Participants were recruited from the outpatient diabetes clinic of a University Hospital in Athens, Greece.

The primary outcome was time spent in euglycaemic range (TIR: 70-140mg/dl) during the diet period. Secondary outcomes were: (a) time spent below euglycaemic range (TBR: <70mg/dl); (b) time spent above euglycaemic range (TAR: >140mg/dl); (c) glycaemic variability and (d) insulin needs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Dietary intervention

Behavioral

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

Primary outcomes

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

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

The Effect of Three Different Types of Diet on Glycemia Assessed by Continuous Glucose Monitoring in Patients With Type 1 Diabetes on Multiple Daily Insulin Treatment

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2020
Registry last updated
Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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