Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer (REHNIS)

University of Pittsburgh

Status and phase

Completed

Phase 1

Conditions

Insulin Resistance

Treatments

Other: Placebo

Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Other

Identifiers

NCT02124681

PRO13060248

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

21 to 69 years old

Volunteers

Accepts Healthy Volunteers

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%