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Completed

NCT Number: NCT01326533

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

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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh, Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

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

Other names: Plaquenil

Placebo

Other

Thirteen weeks of oral placebo provided as capsules

Other names: microcellulose placebo

Primary outcomes

  1. Insulin Sensitivity

    Time frame: 13 weeks after baseline measurement

    Change from baseline in the insulin sensitivity index (Si)

Secondary outcomes

  1. Beta Cell Function

    Time frame: 13 weeks after baseline measurement

    Change from baseline in the disposition index (DI)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Mar 31, 2011
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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