Different Dietary Interventions and Glycemia in T1DM

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Dietary intervention

• Registration Number: NCT04343131
• Lead Sponsor: National and Kapodistrian University of Athens

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).

Detailed Description

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference diet	Dietary intervention	Reference diet for 7 days
Mediterranean diet	Dietary intervention	Mediterranean diet for 7 days
Low-carb/high protein diet	Dietary intervention	Low-carb/high protein diet for 7 days

Primary Outcome Measures

Name	Time	Method
Percentage of time spent with glucose levels between 70-140 mg/dl	7 days	Percentage of time spent with glucose levels between 70-140 mg/dl