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

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
hydroxychloroquine
Placebo
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pre-diabetes focused on measuring pre-diabetes, hydroxychloroquine, frequently sampled intravenous glucose tolerance testing, insulin resistance, insulin secretion, glucose tolerance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > or = 18, able to provide informed consent
  2. Body-mass index greater than or equal to 25

  3. 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
  4. Negative pregnancy test for women with childbearing potential

Exclusion Criteria:

  1. Diagnosis of diabetes mellitus Type 1 or Type 2
  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
  3. Oral corticosteroid use in prior six months, or expectation of needing corticosteroid therapy in upcoming six months
  4. Known allergy or intolerance to HCQ
  5. Known glucose-6 phosphate dehydrogenase deficiency
  6. Known eye disease associated with retinal pigmentation abnormalities
  7. Known diabetic retinopathy requiring past or planned laser therapy
  8. Inability to comply with visit schedule and protocol requirements
  9. Inability to manage and take medication as instructed
  10. Current or planned pregnancy in upcoming 12 months
  11. 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
  12. Anemia (HGB < 9)
  13. Any history of bariatric (weight loss) surgery
  14. Current use of the medication Glucophage (metformin)
  15. Weight changes of 6 pounds or more in the past 4 weeks
  16. 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

Sites / Locations

  • University of Pittsburgh, Montefiore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hydroxychloroquine

Placebo

Arm Description

Thirteen weeks of daily hydroxychloroquine following FSIGTT testing

Thirteen weeks of daily placebo following FSIGTT testing

Outcomes

Primary Outcome Measures

Insulin Sensitivity
Change from baseline in the insulin sensitivity index (Si)

Secondary Outcome Measures

Beta Cell Function
Change from baseline in the disposition index (DI)

Full Information

First Posted
March 29, 2011
Last Updated
January 28, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01326533
Brief Title
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
Official Title
Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
pre-diabetes, hydroxychloroquine, frequently sampled intravenous glucose tolerance testing, insulin resistance, insulin secretion, glucose tolerance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydroxychloroquine
Arm Type
Experimental
Arm Description
Thirteen weeks of daily hydroxychloroquine following FSIGTT testing
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Thirteen weeks of daily placebo following FSIGTT testing
Intervention Type
Drug
Intervention Name(s)
hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
microcellulose placebo
Intervention Description
Thirteen weeks of oral placebo provided as capsules
Primary Outcome Measure Information:
Title
Insulin Sensitivity
Description
Change from baseline in the insulin sensitivity index (Si)
Time Frame
13 weeks after baseline measurement
Secondary Outcome Measure Information:
Title
Beta Cell Function
Description
Change from baseline in the disposition index (DI)
Time Frame
13 weeks after baseline measurement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico Toledo, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26197707
Citation
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.
Results Reference
derived

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

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