Different Dietary Interventions and Glycemia in T1DM

N

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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