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NCT05213988 Clinical Trial

Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies

Glucose Metabolism Disorders Clinical Trial

Official title:
Effects on GLUcose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic STrategies Against Diabetes-Related Metabolic Diseases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05213988
Other study ID # GLUCO-STAR
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 30, 2018
Est. completion date January 1, 2025

Study information
Verified date January 2022
Source Azienda Ospedaliero, Universitaria Pisana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - age 18-65 years - both males and females Exclusion Criteria: - acute or chronic conditions influencing glucose and lipid metabolism - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Intermittent Fasting
Intermittent fasting meal pattern
Drug:
• Fibrates
Bezafibrate 400 mg/day
Dietary Supplement:
• Low-Carbohydrate/High-Protein diet
Low-calorie, low-carbohydrate, high-protein diet

Locations
Country Name City State
Italy Azienda Ospedaliero-Universitaria Pisana Pisa PI

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucose tolerance Glucose tolerance will be measured as the area under the curve of plasma glucose levels in response to a 180-minute 75g oral glucose tolerance test (OGTT) 180 minutes
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