Dietary Fat and Endothelial Function in Type 1 Diabetes

NCT04812782 | Completed

• 1 other identifier: Dietary Fat in Type 1 Diabetes
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of the add-on of extra vergin olive oil or butter to a high glycemic index meal on endothelial function in subjects with type 1 Diabetes and healthy subjects.

Conditions

Type 1 Diabetes

Keywords

Endothelial function; FMD; gastric emptying; post prandial glycemia; dietary fat; EVOO; butter

Outcome Measures

Primary Outcomes (1)

• Change of Endothelial function from pre meal to post meal period

  Flow mediated dilation technique by ultrasound

  before meal, 1 hour, 3 hour, 5 hour after meal

Secondary Outcomes (2)

• Serum glucose

  before meal, 1 hour, 2 hour, 3 hour, 4 hour, 5 hour after meal

• Gastric emptying rate

  before meal, 15, 90, 120, 180, 240, 300 minutes after meal

Study Arms (2)

EVOO-Butter

EXPERIMENTAL

All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with EVOO and the second with butter.

Dietary Supplement: EVOO supplementation; Dietary Supplement: Butter supplementation

Butter-EVOO

EXPERIMENTAL

All patients and control subjects who met inclusion and exclusion criteria, and signed the Informed Consent, were scheduled for the two study visits, one week apart, during which each participant received two types of high GI meal: the first enriched with Butter and the second with EVOO

Dietary Supplement: EVOO supplementation; Dietary Supplement: Butter supplementation

Interventions

EVOO supplementation DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO

Butter-EVOO; EVOO-Butter

Butter supplementation DIETARY_SUPPLEMENT

We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter

Butter-EVOO; EVOO-Butter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years,
• diagnosis of type 1 diabetes since at least 1 year,
• HbA1c \<8.5% (69 mmol/mol),
• stable insulin therapy for at least 3 months before the enrolment into the study

You may not qualify if:

• pregnancy, celiac disease, history of cardiovascular diseases, hypertension, hyperlipidemia, retinopathy, nephropathy, neuropathy, and ongoing treatment with vasoactive drugs.

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

University Magna Graecia

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Cross-over, interventional, controlled study.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 24, 2021
• Study Start: February 12, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

IT (1)