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Metabolic Effects of Hydroxychloroquine (MetaHcQ)

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ClinicalTrials.gov Identifier: NCT02026232
Recruitment Status : Suspended (COVID-19)
First Posted : January 1, 2014
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The basic plan of the study is to randomize otherwise healthy subjects with type 2 diabetes to hydroxychloroquine, 200 mg twice daily or placebo.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Hydroxychloroquine Other: Hydroxychloroquine Placebo Not Applicable

Detailed Description:
Hydroxychloroquine is a medicine that has been used for a long time to treat patients with malaria, rheumatoid arthritis, lupus and other conditions. It is closely related to chloroquine but with a better side effect profile for long term use. In treating these conditions it was discovered to have some beneficial properties like lowering cholesterol and lowering sugar in the blood of those who have diabetes. The mechanisms underlying these effects are unknown. In animal studies, we have discovered that chloroquine appears to decrease glucose, lower blood pressure and decrease atherosclerosis (hardening of the arteries). This collection of problems commonly occurs in the metabolic syndrome and diabetes mellitus, which affects over 20% and 7% of adults in Western countries respectively. We have recently looked at the effects of chloroquine on the metabolic syndrome in humans which showed that small doses given for a short period of time would reduce insulin resistance in patients with the metabolic syndrome. Several population studies have shown similar effects with hydroxychloroquine. Since hydroxychloroquine is similar to chloroquine, we thus expect similar effects on blood glucose, blood pressure and blood cholesterol in type 2 diabetes. This offers a unique opportunity to develop a novel approach for lowering blood pressure, lipids (cholesterol and triglycerides), and glucose in people at risk for heart disease

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Metabolic Effects of Hydroxychloroquine
Study Start Date : March 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: hydroxychloroquine
hydroxychloroquine twice daily for 4 weeks
Drug: Hydroxychloroquine
200mg twice daily
Other Names:
  • Plaquenil
  • Quineprox

Placebo Comparator: Placebo
hydroxychloroquine placebo twice daily for 4 weeks
Other: Hydroxychloroquine Placebo
200mg placebo twice daily
Other Name: placebo




Primary Outcome Measures :
  1. Insulin sensitivity determined by hyperinsulinemic euglycemic clamp [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Effect of HCQ on fasting blood glucose [ Time Frame: 4 weeks ]
  2. Effect of HCQ on fasting low density lipoprotein [ Time Frame: 4 weeks ]
  3. Effect of HcQ on serum biomarkers of inflammation [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects between the age of 18 and 75, either gender, any ethnic group
  • Subjects must have type 2 diabetes and the following:
  • A1c of 6.5-9.0%
  • Treated with at least 1000 mg of metformin daily with or without a dipeptidyl peptidase-4(DPP4)inhibitor, a sulfonylurea (glipizide, glyburide, glimepiride),bromocriptine or colesevelam.
  • Subjects should have a BMI >27

Exclusion Criteria:

  • Prior treatment with chloroquine or hydroxychloroquine as follows:

    1. any exposure in the past 2 years,
    2. >30 days of therapy if exposure was between 2 and 5 years ago,
    3. >90 days of therapy if exposure was between 5 and 10 years ago,
    4. >6 months of therapy if exposure was 10 to 20 years ago,
    5. >1 year of therapy if exposure was 20 to 30 years ago,
    6. No limit if last exposure was >30 years ago, e.g. during the Vietnam conflict.
  • Morbid obesity (BMI >45)
  • Coronary artery disease or other vascular disease
  • History of stroke
  • Serum creatinine >-4 mg/dl for women and >-5 mg/dl for men.
  • Seizure disorder
  • History of psoriasis
  • Hematologic disorders, including anemia (WHO criteria for anemia:hemoglobin <13g/dL in men and <12 g/dL in women)
  • Current malignancy or active treatment for recurrence prevention,e.g. tamoxifen. Cancer considered to be cured, either as a result of surgery or other treatment is not exclusionary.
  • Asthma requiring daily beta agonist therapy or intermittent oral steroids is exclusionary. Inhaled steroids are acceptable. Obstructive sleep apnea will be allowed if continuous positive airway pressure(CPAP) or other therapy has been stable for 6 months. Other active respiratory diseases are excluded.
  • Treatment with 50mg or greater of Metoprolol or treatment with digoxin
  • Liver disease, or Liver Function Test >2 times normal
  • Active infection (including HIV)
  • Serious illness requiring ongoing medical care or medication
  • Treatment with atypical anti-psychotic medication. Treatment with any other medication for psychiatric illness, unless on a stable dose for 6 weeks prior to enrollment. Patients with unstable psychiatric disorders are excluded per the decision of the study MD regardless of medication history.
  • Taking any of the following lipid lowering medications: niacin, fibrates, and greater than 1 gm/day of fish oils
  • Uncontrolled hypertension (BP >150/90 mm Hg) at enrollment
  • Need for daily Over The Counter medications, or currently taking cimetidine or >1000 IU vitamin E daily and unwilling to reduce or discontinue vitamin E or discontinue cimetidine for the duration of the study. Patients taking more than 1000 IU vitamin E daily should reduce or discontinue the vitamin for 30 days before randomization.
  • Pregnant or lactating women, or women intending to become pregnant
  • Women not using adequate birth control (hormonal birth control is acceptable, also double barrier)
  • QT corrected >450 msec on screening ECG
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026232


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Clay F. Semenkovich, M.D. Washington University School of Medicine
Additional Information:
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02026232    
Other Study ID Numbers: 201110258
201110258 ( Other Identifier: Washington University )
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Washington University School of Medicine:
Type 2 Diabetes
Overweight
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents