New protocols started in FY13: 1. 13-DK-0057: Short Term Effects of Leptin Withdrawal or Initiation in Lipodystrophy Independent of Energy Intake. PI Rebecca Brown, MD. ClinicalTrials.gov Identifier: NCT01778556. 2. 13-DK-0136: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, 2-Period Crossover Study to Evaluate the Effect of RM-493 on Energy Expenditure in Obese Subjects. PI. Monica Skarulis, MD. ClinicalTrials.gov Identifier: NCT01867437. 3. 13-Dk-0013: Impact of Chronic Cold Exposure on Energy Metabolism in Humans. PI, Francesco Celi, MD. ClinicalTrials.gov Identifier: NCT01730105. 4. 13-DK-0002: Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E. PI, Yaron Rotman, MD. ClinicalTrials.gov identifier: NCT01792115. 5. 13-DK-0142: The Physiology of Fatigue in Patients With Chronic Liver Disease. PI, Yaron Rotman, MD. ClinicalTrials.gov identifier: NCT01867385. 6. 13-HG-0053: The NIH Mini Study: Metabolism, Infection and Immunity in Inborn Errors of Metabolism. PI, Peter McGuire, MD. ClinicalTrials.gov Identifier: NCT01780168 Research highlights: 1. Our clinical support services include routine measurements of resting metabolic rate in patients that ranges from young children (12 months) in the Undiagnosed Disease Program (UDP) to severely obese patients. The experiences led to an invited review manuscript (European Journal of Clinical Nutrition) that I coauthored with Dr. Tricia Psato from the Clinical Center Department of Nutrition. We highlighted the advancements, rewards and challenges of the technique, and the precautions and interpretations that are often difficult in such clinical populations. 2. A long-term collaboration with Dr. Richard Cannon (NHLBI) in the Keep-the-Beat II Study led to one manuscript in the International Journal of Obesity, where we found that hyperinsulinemia in overweight or obese women was associated with increased extremity muscle mass, which was partially reversible with reduction in fasting insulin concentration, suggesting the stimulatory effects of insulin on skeletal muscle in the overweight and obese. 3. In a collaboration with researchers at NIDA and NIAAA in a sub-study nested in the protocol Study of the Phenotype of Overweight and Obese Adults (07-DK-0077), we found that, when compared to BMI-matched normal controls, chronic cannabis smoking was associated with visceral adiposity and adipose tissue insulin resistance but not with hepatic steatosis, insulin insensitivity, impaired pancreatic β-cell function, or glucose intolerance. 4. We have been collaborating with investigators inside and outside of the NIH in field research using accelerometers. It continues to result in manuscripts. The Iceland study cohort revealed that there were gender differences in accelerometer-associated physical activity, even after adjusting for the difference in walking speed, which suggests that there were biomechanical differences in gait patterns between genders in the older populations. The other paper, we used the objective accelerometer to validate a subjective physical activity survey in an older population in the Netherlands. Services rendered: energy expenditure by whole-room respiratory chambers (444), resting energy expenditure by metabolic carts (290), graded exercise tests (102), experimental food behavior tests (103), and body composition (274 DXA, 204 Bod Pod), all of which were significantly increased from FY12.
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