Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2014-11-30
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mediterranean diet
Mediterranean diet for 7 days
Dietary intervention
Crossover dietary manipulation using three different types of diet for 7 days each
Low-carb/high protein diet
Low-carb/high protein diet for 7 days
Dietary intervention
Crossover dietary manipulation using three different types of diet for 7 days each
Reference diet
Reference diet for 7 days
Dietary intervention
Crossover dietary manipulation using three different types of diet for 7 days each
Interventions
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Dietary intervention
Crossover dietary manipulation using three different types of diet for 7 days each
Eligibility Criteria
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Inclusion Criteria
* 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
* Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis
ALL
No
Sponsors
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National and Kapodistrian University of Athens
OTHER
Responsible Party
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Alexandros Kokkinos
Associate Professor in Internal Medicine
Principal Investigators
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Alexandros Kokkinos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical School, National and Kapodistrian University of Athens, Laiko Hospital
Other Identifiers
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Diet in T1DM
Identifier Type: -
Identifier Source: org_study_id
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