Back to resultsEffects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies
Primary Purpose
Glucose Metabolism Disorders
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intermittent Fasting
Fibrates
Low-Carbohydrate/High-Protein diet
Sponsored by
About this trial
This is an interventional basic science trial for Glucose Metabolism Disorders
Eligibility Criteria
Inclusion Criteria:
- age 18-65 years
- both males and females
Exclusion Criteria:
- acute or chronic conditions influencing glucose and lipid metabolism
- pregnancy
Sites / Locations
- Azienda Ospedaliero-Universitaria Pisana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
Low-Carbohydrate/High-Protein Diet
Fibrate
Intermittent Fasting
Control
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05213988
First Posted
December 6, 2021
Last Updated
January 25, 2022
Sponsor
Azienda Ospedaliero, Universitaria Pisana
1. Study Identification
Unique Protocol Identification Number
NCT05213988
Brief Title
Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies
Official Title
Effects on GLUcose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic STrategies Against Diabetes-Related Metabolic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero, Universitaria Pisana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The investigators aim to examine the impact of changes in plasma lipoproteins induced by nutritional and pharmacological interventions on glucose homeostasis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-Carbohydrate/High-Protein Diet
Arm Type
Experimental
Arm Title
Fibrate
Arm Type
Experimental
Arm Title
Intermittent Fasting
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Intermittent Fasting
Intervention Description
Intermittent fasting meal pattern
Intervention Type
Drug
Intervention Name(s)
Fibrates
Intervention Description
Bezafibrate 400 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-Carbohydrate/High-Protein diet
Intervention Description
Low-calorie, low-carbohydrate, high-protein diet
Primary Outcome Measure Information:
Title
Glucose tolerance
Description
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)
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-65 years
both males and females
Exclusion Criteria:
acute or chronic conditions influencing glucose and lipid metabolism
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natali, MD
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
State/Province
PI
ZIP/Postal Code
56127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies
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