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

NCT ID: NCT02910076

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31

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.

Conditions

Diabetes Type Two

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy volunteers

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

200 MG Plaquenil three times a day

Diabetes patients

Group Type: EXPERIMENTAL

Hydroxychloroquine

Intervention Type: DRUG

200 MG Plaquenil three times a day

Interventions

Hydroxychloroquine

200 MG Plaquenil three times a day

Intervention Type: DRUG

Other Intervention Names

Plaquenil

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• Malignancy
• Steroids or NSAID on a daily basis

B. Diabetes patients

• Hypoglycemic medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gil Leibowitz

Role: CONTACT

GLEIB@hadassah.org.il

Other Identifiers

0059-16-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id