Pre-diabetesPhase 4NCT01326533
Reducing Risk of Type 2 Diabetes: Hydroxychloroquine Use in Pre-Diabetes
A Phase 4 study testing hydroxychloroquine in people with Pre-diabetes, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 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.
Read the 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.
- Conditions
- Pre-diabetes
- Being tested
- hydroxychloroquine, Placebo
- Keywords
- pre-diabetes, hydroxychloroquine, frequently sampled intravenous glucose tolerance testing, insulin resistance, insulin secretion, glucose tolerance
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules
PlaceboOther
Also called microcellulose placebo
Thirteen weeks of oral placebo provided as capsules
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine | Experimental | Thirteen weeks of daily hydroxychloroquine following FSIGTT testing Receives: Drug: hydroxychloroquine |
| Placebo | Placebo comparator | Thirteen weeks of daily placebo following FSIGTT testing Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Change from baseline in the insulin sensitivity index (Si)
Measured: 13 weeks after baseline measurement
Secondary outcomes (1)
Beta Cell Function
Change from baseline in the disposition index (DI)
Measured: 13 weeks after baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Toledo, University of Pittsburgh
- Investigators
- Frederico Toledo, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326533
- Sponsor's protocol ID
- DK082878
- Other IDs
- 5R21DK082878-02
- Status last verified
- Jan 2016
- First submitted
- 29 Mar 2011
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26197707
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Action of Hydroxychloroquine in Reducing Risk of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01326533
- Acronym / sponsor ID
- DK082878
- Conditions
- Pre-diabetes
- Keywords
- pre-diabetes, hydroxychloroquine, frequently sampled intravenous glucose tolerance testing, insulin resistance, insulin secretion, glucose tolerance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Mar 2011 (estimated)
- Results
- Posted 29 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine | Experimental | Drug: hydroxychloroquineThirteen weeks of daily hydroxychloroquine following FSIGTT testing |
| Placebo | Placebo comparator | Other: PlaceboThirteen weeks of daily placebo following FSIGTT testing |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Negative pregnancy test for women with childbearing potential
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquineAlso: PlaquenilThirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules | Drug | hydroxychloroquine |
| PlaceboAlso: microcellulose placeboThirteen weeks of oral placebo provided as capsules | Other | Placebo |
Primary outcome
Insulin Sensitivity
Time frame: 13 weeks after baseline measurement
Change from baseline in the insulin sensitivity index (Si)
1 secondary outcome
Beta Cell Function
Time frame: 13 weeks after baseline measurement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26197707Wasko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederico Toledo, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hydroxychloroquine in people with Pre-diabetes, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity (time frame: 13 weeks after baseline measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.