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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT02910076
Collaborator
(none)
40
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. glucose level [the change in glucose level between baseline and after three hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes

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

    1. 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

    1. Diabetes patients

    • Inclusion Criteria:

    • Age: 20-60

    • Diabetes type two

    • Untreated or on metformin treatment

    • Exclusion Criteria:

    • Hypoglycemic medications

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT02910076
    Other Study ID Numbers:
    • 0059-16-HMO-CTIL
    First Posted:
    Sep 21, 2016
    Last Update Posted:
    Sep 21, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Hydroxychloroquine

    Study Results

    No Results Posted as of Sep 21, 2016