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

NCT01326533 | Completed Phase 4 Results DMC

• 2 other identifiers: DK0828785R21DK082878-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-diabetes

Keywords

pre-diabetes; hydroxychloroquine; frequently sampled intravenous glucose tolerance testing; insulin resistance; insulin secretion; glucose tolerance

Outcome Measures

Primary Outcomes (1)

• Insulin Sensitivity

  Change from baseline in the insulin sensitivity index (Si)

  13 weeks after baseline measurement

Secondary Outcomes (1)

• Beta Cell Function

  13 weeks after baseline measurement

Study Arms (2)

hydroxychloroquine

EXPERIMENTAL

Thirteen weeks of daily hydroxychloroquine following FSIGTT testing

Drug: hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Thirteen weeks of daily placebo following FSIGTT testing

Other: Placebo

Interventions

hydroxychloroquine DRUG

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

Also known as: Plaquenil

hydroxychloroquine

Placebo OTHER

Thirteen weeks of oral placebo provided as capsules

Also known as: microcellulose placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh, Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Wasko MC, McClure CK, Kelsey SF, Huber K, Orchard T, Toledo FG. Antidiabetogenic effects of hydroxychloroquine on insulin sensitivity and beta cell function: a randomised trial. Diabetologia. 2015 Oct;58(10):2336-43. doi: 10.1007/s00125-015-3689-2. Epub 2015 Jul 22.

  PMID: 26197707 DERIVED

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Frederico Toledo
• Organization: University of Pittsburgh

.toledofs@upmc.edu

412-692-2848

Study Officials

• Frederico Toledo, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 31, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2014
• Last Updated: February 26, 2016
• Results First Posted: January 29, 2016

Record last verified: 2016-01

Locations

US (1)