Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes

Pre-diabetes Clinical Trial

Official title:

Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326533
• Other study ID #: DK082878
• Secondary ID: 5R21DK082878-02
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2011
• Last updated: January 28, 2016
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the short-term effects of the antimalarial medication, hydroxychloroquine (HCQ), compared with placebo using frequently sampled intravenous glucose tolerance testing (FSIGTT) methodology to study changes in insulin secretion and glucose tolerance in subjects at risk for developing Type 2 diabetes.

Description:

Diabetes is approaching epidemic proportions in the United States. This study evaluates the mechanisms of action of a generic drug that may have effects on glucose metabolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Age > or = 18, able to provide informed consent

2. Body-mass index greater than or equal to 25

3. Presence of at least one indicator of insulin resistance from the following list:

• Family history of Type 2 diabetes (parent, sibling)

• Fasting glucose 100 - 125 mg/dl

• Fasting serum insulin greater than or equal to 7uU/ml

• Personal history of gestational diabetes

4. Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

1. Diagnosis of diabetes mellitus Type 1 or Type 2

2. Active autoimmune disease, chronic infection, current malignancy (excluding basal cell carcinoma), or other active inflammatory state that, in the opinion of the investigators, would affect insulin sensitivity

3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months

4. Known allergy or intolerance to HCQ

5. Known glucose-6 phosphate dehydrogenase deficiency

6. Known eye disease associated with retinal pigmentation abnormalities

7. Known diabetic retinopathy requiring past or planned laser therapy

8. Inability to comply with visit schedule and protocol requirements

9. Inability to manage and take medication as instructed

10. Current or planned pregnancy in upcoming 12 months

11. Inability or unwillingness to use reliable method of contraception (for women of childbearing years, men, or men's partners with childbearing potential), such as oral contraceptive pills, barrier method (diaphragm and condom with spermicide), intrauterine device, or depo-provera injections for 3 months prior to enrollment

12. Anemia (HGB < 9)

13. Any history of bariatric (weight loss) surgery

14. Current use of the medication Glucophage (metformin)

15. Weight changes of 6 pounds or more in the past 4 weeks

16. Any other underlying or concomitant condition, which in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Drug:
• hydroxychloroquine
Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules

Other:
• Placebo
Thirteen weeks of oral placebo provided as capsules

Locations

Country	Name	City	State
United States	University of Pittsburgh, Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Change from baseline in the insulin sensitivity index (Si)	13 weeks after baseline measurement	No
Secondary	Beta Cell Function	Change from baseline in the disposition index (DI)	13 weeks after baseline measurement	No