Participant receives both curcumin and prednisolone. Curcumin for 11 days, prednisolone for 10 days. Curcumin: 2 tablets (each contains 100 mg curcumin) twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon: 50 mg (capsule) every morning

Participant receives prednisolone.placebo and curcumin-placebo. Curcumin-placebo for 11 days, prednisolone-placebo for 10 days. Curcumin-placebo: 2 tablets twice daily. Prednisolon-placebo: One capsule every morning.

Insulin Resistance

Non-Alcoholic Fatty Liver Disease

Curcumin is given together with prednisolone

Curcumin Liposome

Prednisolone is given together with curcumin-placebo

Prednisolone

Prednisolone-placebo is given together with curcumin-placebo

Placebos

Center for Clinical Metabolic Research

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance in Overweight and Obese Participants

homeostatic model assessment of insulin resistance is calculated before and after intervention

Measured by MR spectroscopy of the liver (unit: %)

Estimated by collecting urin for 4-5 hours, measuring volume of urine and urea concentration

Feces sample before and after intervention

subcutaneously, interstitial measurement (concentration of glucose) every 15 minutes in the intervention period

icare 100 tonometer measurement (unit: mmHg)

measured by bioimpedance (units: kg and %)

MR-spectroscopy measurement (unit: cm3 at L3-level, 1 cm thick slice)

visual analogue scale evaluation (no visible numbers/points, just a clear line)

Evaluated by calculating ingested meal at ad libitum meal at test days (unit: grams and calories)

Visual analogue scale (no points/number visible, just a clear line)

Pernille Høgh Hellmann

Medical Doctor, primary investigator

University Hospital, Gentofte, Copenhagen

After study day 1, participants are randomized (1:1:1) to one of three treatments: 1) Prednisolon and Curcumin, 2) Prednisolon and placebo or 3) Placebo and placebo.

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

Dawood Darbar, MD

Professor of Medicine

Medtronic

Iron Overload

All patients will receive monthly phlebotomies.

phlebitis/phosphatase

The Effect of Curcumin on the Development of Prednisolone-induced Hepatic Insulin Resistance

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

Safety and Efficacy of Iron Reduction by Phlebotomy

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