NCT02910076

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Last Updated

September 21, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

September 1, 2016

Last Update Submit

September 20, 2016

Conditions

Diabetes Type Two

Outcome Measures

Primary Outcomes (1)

  • glucose level

    the change in glucose level between baseline and after three hours

Study Arms (2)

Healthy volunteers

EXPERIMENTAL
Drug: Hydroxychloroquine

Diabetes patients

EXPERIMENTAL
Drug: Hydroxychloroquine

Interventions

HydroxychloroquineDRUG

200 MG Plaquenil three times a day

Also known as: Plaquenil
Diabetes patientsHealthy volunteers

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Malignancy
  • Steroids or NSAID on a daily basis
  • B. Diabetes patients
  • Age: 20-60
  • Diabetes type two
  • Untreated or on metformin treatment
  • Hypoglycemic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Gil Leibowitz

CONTACT

GLEIB@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 21, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Last Updated

September 21, 2016

Record last verified: 2016-08