The Influence of Plaquenil/Hydroxychloroquine (HCQ) on Insulin Secretion

September 20, 2016 updated by: Hadassah Medical Organization
Antimalarials such as hydroxychloroquine (HCQ), are among the oldest prescribed drugs still used in clinical practice. Relatively inexpensive and well tolerated, these drugs have been recognized to be effective in autoimmune diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Interestingly, there is growing evidence of their beneficial impact on cardiovascular risk, particularly diabetes. HCQ therapy can improve balance in patients with unbalanced diabetes. This drug therapy may be a new therapeutic approach for diabetes. There is need for a better understanding of the mechanisms responsible for the improvement of the metabolic response to drug treatment. The investigators hypothesize that treatment with a drug improves the function of the beta cell and its ability to secrete insulin in response to glucose. The investigators will examine the impact of short-term therapy for HCQ in beta cell function in healthy volunteers and in patients with type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Two groups will participate in this study: Healthy volunteers and Diabetes patients

A. Healthy volunteers

  • Inclusion Criteria:

    • Age: 18-40
    • Without acute disease at the day of the experiment.
    • Signed informed consent

  • Exclusion Criteria:

    • Malignancy
    • Steroids or NSAID on a daily basis

B. Diabetes patients

  • Inclusion Criteria:

    • Age: 20-60
    • Diabetes type two
    • Untreated or on metformin treatment

  • Exclusion Criteria:

    • Hypoglycemic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy volunteers
Drug: Hydroxychloroquine
200 MG Plaquenil three times a day
Other Names:
  • Plaquenil
EXPERIMENTAL: Diabetes patients
Drug: Hydroxychloroquine
200 MG Plaquenil three times a day
Other Names:
  • Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucose level
Time Frame: the change in glucose level between baseline and after three hours
the change in glucose level between baseline and after three hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (ESTIMATE)

September 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0059-16-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Type Two

Clinical Trials on Hydroxychloroquine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe