NCT05297110

Brief Summary

This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital). Patients over 18 years of age with:

  1. 1.Arterial hypertension (hypertension).
  2. 2.Or diabetes.
  3. 3.Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease\> 20% according to the Framingham scale (apart from hypertension and diabetes were included.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2021

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

November 17, 2021

Last Update Submit

January 3, 2023

Conditions

Diabetes Mellitus, Type 2Hypertension

Keywords

diabeteshypertensionatherolive

Outcome Measures

Primary Outcomes (2)

  • rate of blood pressure reduction

    blood pressure reduction on 24 hours holter

    90 days

  • rate of fasting glycemia level reduction

    morning glycemic cycle

    90 days

Secondary Outcomes (3)

  • rate of lipid balance variation The secondary endpoint (for the 3 study populations): lipid profile

    90 days

  • rate of hospitalization for cardiovascular disease

    90 days

  • rate of adverse effects

    90 days

Study Arms (2)

atherolive group

ACTIVE COMPARATOR

In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

Drug: atherolive

placebo group

PLACEBO COMPARATOR

In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

Drug: atherolive

Interventions

atheroliveDRUG

In each study population, the patient will be assigned to one of two treatments (atherolive or placebo) using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. The placebo will be prescribed identically.

atherolive groupplacebo group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years of age with:
  • Arterial hypertension (hypertension).
  • Or diabetes.
  • Or one or more other cardiovascular risk factors (AHA, ESC) or risk of cardiovascular disease\> 20% according to the Framingham scale (apart from hypertension and diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fattouma Bourguiba Monastir University Hospital Center

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nouira Semir, Professor

    University of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira Semir, Pr

CONTACT

73106046semir.nouira@rns.tn

Bel Hadj Ali Khaoula, Pr

CONTACT

73106046belhadjalikhaoula@yahoo.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Emergency departement

Study Record Dates

First Submitted

November 17, 2021

First Posted

March 28, 2022

Study Start

August 1, 2021

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

TU(1)