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

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Pre-diabetes

Drug Information available for: Hydroxychloroquine Hydroxychloroquine sulfate

U.S. FDA Resources

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:

Age > or = 18, able to provide informed consent
Body-mass index greater than or equal to 25
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
Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

Diagnosis of diabetes mellitus Type 1 or Type 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
Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
Known allergy or intolerance to HCQ
Known glucose-6 phosphate dehydrogenase deficiency
Known eye disease associated with retinal pigmentation abnormalities
Known diabetic retinopathy requiring past or planned laser therapy
Inability to comply with visit schedule and protocol requirements
Inability to manage and take medication as instructed
Current or planned pregnancy in upcoming 12 months
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
Anemia (HGB < 9)
Any history of bariatric (weight loss) surgery
Current use of the medication Glucophage (metformin)
Weight changes of 6 pounds or more in the past 4 weeks
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

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Hydroxychloroquine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013