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Different Dietary Interventions and Glycemia in T1DM

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dietary intervention

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Glycemia, Continuous glucose monitoring, Diet

Eligibility Criteria

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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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Mediterranean diet

Low-carb/high protein diet

Reference diet

Arm Description

Mediterranean diet for 7 days

Low-carb/high protein diet for 7 days

Reference diet for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04343131

First Posted

April 9, 2020

Last Updated

April 10, 2020

Sponsor

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT04343131

Brief Title

Different Dietary Interventions and Glycemia in T1DM

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

November 2014 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, Glycemia, Continuous glucose monitoring, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mediterranean diet

Arm Type

Active Comparator

Arm Description

Mediterranean diet for 7 days

Arm Title

Low-carb/high protein diet

Arm Type

Active Comparator

Arm Description

Low-carb/high protein diet for 7 days

Arm Title

Reference diet

Arm Type

Active Comparator

Arm Description

Reference diet for 7 days

Intervention Type

Behavioral

Intervention Name(s)

Dietary intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

7 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandros Kokkinos, MD, PhD

Organizational Affiliation

Medical School, National and Kapodistrian University of Athens, Laiko Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Different Dietary Interventions and Glycemia in T1DM

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