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

NCT ID: NCT05213988

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2025-01-01

Brief Summary

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

Detailed Description

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Conditions

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Glucose Metabolism Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Low-Carbohydrate/High-Protein Diet

Group Type EXPERIMENTAL

Low-Carbohydrate/High-Protein diet

Intervention Type DIETARY_SUPPLEMENT

Low-calorie, low-carbohydrate, high-protein diet

Fibrate

Group Type EXPERIMENTAL

Fibrates

Intervention Type DRUG

Bezafibrate 400 mg/day

Intermittent Fasting

Group Type EXPERIMENTAL

Intermittent Fasting

Intervention Type DIETARY_SUPPLEMENT

Intermittent fasting meal pattern

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent Fasting

Intermittent fasting meal pattern

Intervention Type DIETARY_SUPPLEMENT

Fibrates

Bezafibrate 400 mg/day

Intervention Type DRUG

Low-Carbohydrate/High-Protein diet

Low-calorie, low-carbohydrate, high-protein diet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* age 18-65 years
* both males and females

Exclusion Criteria

* acute or chronic conditions influencing glucose and lipid metabolism
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natali

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Natali, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

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Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Site Status

Countries

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Italy

Other Identifiers

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GLUCO-STAR

Identifier Type: -

Identifier Source: org_study_id

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