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

NCT ID: NCT01326533

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-12-31

Brief 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.

Detailed 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.

Conditions

Pre-diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

hydroxychloroquine

Thirteen weeks of daily hydroxychloroquine following FSIGTT testing

Group Type: EXPERIMENTAL

hydroxychloroquine

Intervention Type: DRUG

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

Placebo

Thirteen weeks of daily placebo following FSIGTT testing

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Thirteen weeks of oral placebo provided as capsules

Interventions

hydroxychloroquine

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

Intervention Type: DRUG

Placebo

Thirteen weeks of oral placebo provided as capsules

Intervention Type: OTHER

Other Intervention Names

Plaquenil; microcellulose placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Frederico Toledo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederico Toledo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh, Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015 Oct;58(10):2336-43. doi: 10.1007/s00125-015-3689-2. Epub 2015 Jul 22.

Reference Type: DERIVED

PMID: 26197707 (View on PubMed)

Other Identifiers

5R21DK082878-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK082878

Identifier Type: -

Identifier Source: org_study_id