Different Dietary Interventions and Glycemia in T1DM

National and Kapodistrian University of Athens

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04343131

Diet in T1DM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Mediterranean diet

Active Comparator group

Description:

Mediterranean diet for 7 days

Treatment:

Behavioral: Dietary intervention

Low-carb/high protein diet

Active Comparator group

Description:

Low-carb/high protein diet for 7 days

Treatment:

Behavioral: Dietary intervention

Reference diet

Active Comparator group

Description:

Reference diet for 7 days

Treatment:

Behavioral: Dietary intervention