Different Dietary Interventions and Glycemia in T1DM | NCT04343131

Studies
Different Dietary Interventions and Glycemia in T1DM

NCT04343131

Sponsor

National and Kapodistrian University of Athens

Status

Completed

Last Update Posted

Apr 13, 2020Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Diabetes Mellitus, Type 1

Interventions

Dietary intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Apr 9, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2020

Last Update Posted Date

Apr 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandros Kokkinos, Associate Professor in Internal Medicine, National and Kapodistrian University of AthensPrincipal Investigator

Lead Sponsor

National and Kapodistrian University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mediterranean diet	Active Comparator	Mediterranean diet for 7 days	Behavioral: Dietary intervention
Low-carb/high protein diet	Active Comparator	Low-carb/high protein diet for 7 days	Behavioral: Dietary intervention
Reference diet	Active Comparator	Reference diet for 7 days	Behavioral: Dietary intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary intervention	Behavioral	Crossover dietary manipulation using three different types of diet for 7 days each	Low-carb/high protein diet Mediterranean diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of time spent with glucose levels between 70-140 mg/dl	Percentage of time spent with glucose levels between 70-140 mg/dl	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandros Kokkinos, MD, PhD	Medical School, National and Kapodistrian University of Athens, Laiko Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided