Diabetes Type Two Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 40 |
| Est. completion date | |
| Est. primary completion date | August 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | glucose level | the change in glucose level between baseline and after three hours | Yes |