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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Frederico Toledo, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01326533
First received: March 29, 2011
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Pre-diabetes
Drug: hydroxychloroquine
Other: Sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: Frequently sampled intravenous glucose tolerance testing (FSIGTT) at baseline and 3 months ] [ Designated as safety issue: No ]
    Glucose metabolism, regulated by insulin secretion and sensitivity, as measured by FSIGTT, will improve in subjects with pre-diabetes treated with hydroxychloroquine compared with placebo for approximately 13 weeks.


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydroxychloroquine
Thirteen weeks of daily hydroxychloroquine therapy following FSIGTT testing
Drug: hydroxychloroquine
Thirteen weeks 400 mg oral hydroxychloroquine capsule taken after frequently sampled intravenous glucose tolerance testing (FSIGTT)
Other Name: Plaquenil
Placebo Comparator: Sugar pill
Thirteen weeks of daily sugar pill following FSIGTT testing
Other: Sugar pill
Thirteen weeks oral inert substance taken in capsule daily
Other Name: microcellulose

Detailed Description:

Diabetes is approaching epidemic proportions in the United States. Efforts to implement effective strategies for diabetes prevention have been limited by poor long term adherence to lifestyle modifications and potential side effects and costs of pharmacologic interventions. This study evaluates the mechanisms of action of a generic drug that may be a useful alternative to existing interventions to prevent the development of Type 2 diabetes mellitus.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326533

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Frederico Toledo, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Frederico Toledo, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01326533     History of Changes
Other Study ID Numbers: DK082878
Study First Received: March 29, 2011
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
pre-diabetes
hydroxychloroquine
frequently sampled intravenous glucose tolerance testing
insulin resistance
insulin secretion
glucose tolerance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Prediabetic State
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Hydroxychloroquine
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antirheumatic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014