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

Not Applicable

• Conditions: Glucose Metabolism Disorders
• Interventions: Dietary Supplement: Low-Carbohydrate/High-Protein diet; Drug: Fibrates; Dietary Supplement: Intermittent Fasting

• Registration Number: NCT05213988
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-30
• Study First Submitted: 2021-12-06
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-25
• Last Update Submitted: 2022-01-25
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age 18-65 years
• both males and females

Exclusion Criteria

• acute or chronic conditions influencing glucose and lipid metabolism
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Carbohydrate/High-Protein Diet	Low-Carbohydrate/High-Protein diet	-
Fibrate	Fibrates	-
Intermittent Fasting	Intermittent Fasting	-

Primary Outcome Measures

Name	Time	Method
Glucose tolerance	180 minutes	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)

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy