Effects on Glucose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic Strategies
Sponsor
Azienda Ospedaliero, Universitaria Pisana (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05213988
Collaborator
(none)
50
1
4
77.1
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Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effects on GLUcose Homeostasis of Changes in Plasma Lipoproteins Induced by Nutritional and Pharmacologic STrategies Against Diabetes-Related Metabolic Diseases
Actual Study Start Date
:
Jul 30, 2018
Anticipated Primary Completion Date
:
Jan 1, 2025
Anticipated Study Completion Date
:
Jan 1, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-Carbohydrate/High-Protein Diet
|
Dietary Supplement: Low-Carbohydrate/High-Protein diet
Low-calorie, low-carbohydrate, high-protein diet
|
| Experimental: Fibrate
|
Drug: Fibrates
Bezafibrate 400 mg/day
|
| Experimental: Intermittent Fasting
|
Dietary Supplement: Intermittent Fasting
Intermittent fasting meal pattern
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- 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)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
age 18-65 years
-
both males and females
Exclusion Criteria:
-
acute or chronic conditions influencing glucose and lipid metabolism
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliero-Universitaria Pisana | Pisa | PI | Italy | 56127 |
Sponsors and Collaborators
- Azienda Ospedaliero, Universitaria Pisana
Investigators
- Principal Investigator: Andrea Natali, MD, University of Pisa
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Andrea Natali,
Full Professor,
Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT05213988
Other Study ID Numbers:
- GLUCO-STAR
First Posted:
Jan 28, 2022
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: