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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2018

Interventions

  • Drug: Hydroxychloroquine
    • 200 MG Plaquenil three times a day

Arms, Groups and Cohorts

  • Experimental: Healthy volunteers
  • Experimental: Diabetes patients

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Gil Leibowitz, GLEIB@hadassah.org.il

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.