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

H

Hadassah Medical Center

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Diabetes Type Two

Treatments

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT02910076
0059-16-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Healthy volunteers
Experimental group
Treatment:
Drug: Hydroxychloroquine
Diabetes patients
Experimental group
Treatment:
Drug: Hydroxychloroquine

Trial contacts and locations

0

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Central trial contact

Gil Leibowitz

Data sourced from clinicaltrials.gov

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