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OpenTrials
Completed

NCT Number: NCT02124681

Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer

Current options to treat insulin resistance in diabetes are fairly limited. For this reason, novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ) has poorly understood effects on blood sugar metabolism. In this study, the investigators will examine the mechanisms by which this drug affects glucose metabolism and which cells are affected. Findings emanating from this project will help establish whether HCQ may be a viable treatment for disorders of glucose metabolism.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, 15234, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 21-69 years-old;
  • BMI 28-40;
  • Presence of at least one of the following markers of insulin resistance: a) fasting hyperinsulinemia (>7 uU/ml by ultrasensitive insulin assay); impaired fasting glucose (100-125 mg/dl); prior history of impaired glucose tolerance provided by the participant; history of previous gestational diabetes; history of PCOS; waist circumference >40" (men) or >35" (women) (cut-offs from ATP-III criteria for metabolic syndrome).

Exclusion criteria

  • Pregnancy, or unable/unwilling to avoid pregnancy during the study;
  • Unstable cardiopulmonary disease, hepatitis, liver dysfunction, renal insufficiency, or any other medical condition affecting glucose metabolism or safety during the study;
  • Diabetes;
  • Medications that affect glucose metabolism: (e.g. systemic glucocorticoids, antipsychotics);
  • History of hypersensitivity to local lidocaine, similar anesthetics, or HCQ;
  • History of G6PDH deficiency;
  • History of retinopathy;
  • Weight instability (>3Kg of weight change in the past three months);
  • Bariatric surgery in the last two years, intention to lose weight or engage in exercise regimen during study;
  • Alcohol intake >1 drink/day (averaged);
  • Hemoglobin <10g%

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks

Placebo

Other

Placebo PO for 13±1 weeks

Primary outcomes

  1. Insulin sensitivity in muscle and liver

    Time frame: 13±1 weeks

Secondary outcomes

  1. biomarkers of inflammation

    Time frame: 13±1 weeks

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: REHNIS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 28, 2014
Registry last updated
Jun 6, 2017

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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