drugset / Trial / NCT01616082
Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The purpose of this study is to better understand the different ways our bodies burn fat which may be important for obesity, diabetes, and cardiovascular disease.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-11
- Completion
- 2012-11
Publications
- Background Holloway GP, Bonen A, Spriet LL. Regulation of skeletal muscle mitochondrial fatty acid metabolism in lean and obese individuals. Am J Clin Nutr. 2009 Jan;89(1):455S-62S. doi: 10.3945/ajcn.2008.26717B. Epub 2008 Dec 3.
- Background Simoneau JA, Kelley DE. Altered glycolytic and oxidative capacities of skeletal muscle contribute to insulin resistance in NIDDM. J Appl Physiol (1985). 1997 Jul;83(1):166-71. doi: 10.1152/jappl.1997.83.1.166.
- Background Ukropcova B, Sereda O, de Jonge L, Bogacka I, Nguyen T, Xie H, Bray GA, Smith SR. Family history of diabetes links impaired substrate switching and reduced mitochondrial content in skeletal muscle. Diabetes. 2007 Mar;56(3):720-7. doi: 10.2337/db06-0521.
- Background Zurlo F, Lillioja S, Esposito-Del Puente A, Nyomba BL, Raz I, Saad MF, Swinburn BA, Knowler WC, Bogardus C, Ravussin E. Low ratio of fat to carbohydrate oxidation as predictor of weight gain: study of 24-h RQ. Am J Physiol. 1990 Nov;259(5 Pt 1):E650-7. doi: 10.1152/ajpendo.1990.259.5.E650.
- Background Koves TR, Ussher JR, Noland RC, Slentz D, Mosedale M, Ilkayeva O, Bain J, Stevens R, Dyck JR, Newgard CB, Lopaschuk GD, Muoio DM. Mitochondrial overload and incomplete fatty acid oxidation contribute to skeletal muscle insulin resistance. Cell Metab. 2008 Jan;7(1):45-56. doi: 10.1016/j.cmet.2007.10.013.
- Background Salehzadeh F, Rune A, Osler M, Al-Khalili L. Testosterone or 17beta-estradiol exposure reveals sex-specific effects on glucose and lipid metabolism in human myotubes. J Endocrinol. 2011 Aug;210(2):219-29. doi: 10.1530/JOE-10-0497. Epub 2011 Jun 1.
- Background Hamadeh MJ, Devries MC, Tarnopolsky MA. Estrogen supplementation reduces whole body leucine and carbohydrate oxidation and increases lipid oxidation in men during endurance exercise. J Clin Endocrinol Metab. 2005 Jun;90(6):3592-9. doi: 10.1210/jc.2004-1743. Epub 2005 Mar 8.
- Background Krssak M, Falk Petersen K, Dresner A, DiPietro L, Vogel SM, Rothman DL, Roden M, Shulman GI. Intramyocellular lipid concentrations are correlated with insulin sensitivity in humans: a 1H NMR spectroscopy study. Diabetologia. 1999 Jan;42(1):113-6. doi: 10.1007/s001250051123.
- Background Franklin RM, Kanaley JA. Intramyocellular lipids: effect of age, obesity, and exercise. Phys Sportsmed. 2009 Apr;37(1):20-6. doi: 10.3810/psm.2009.04.1679.
- Background Goodpaster BH, Kelley DE, Wing RR, Meier A, Thaete FL. Effects of weight loss on regional fat distribution and insulin sensitivity in obesity. Diabetes. 1999 Apr;48(4):839-47. doi: 10.2337/diabetes.48.4.839.
- Background Lara-Castro C, Newcomer BR, Rowell J, Wallace P, Shaughnessy SM, Munoz AJ, Shiflett AM, Rigsby DY, Lawrence JC, Bohning DE, Buchthal S, Garvey WT. Effects of short-term very low-calorie diet on intramyocellular lipid and insulin sensitivity in nondiabetic and type 2 diabetic subjects. Metabolism. 2008 Jan;57(1):1-8. doi: 10.1016/j.metabol.2007.05.008.
- Background Tamura Y, Tanaka Y, Sato F, Choi JB, Watada H, Niwa M, Kinoshita J, Ooka A, Kumashiro N, Igarashi Y, Kyogoku S, Maehara T, Kawasumi M, Hirose T, Kawamori R. Effects of diet and exercise on muscle and liver intracellular lipid contents and insulin sensitivity in type 2 diabetic patients. J Clin Endocrinol Metab. 2005 Jun;90(6):3191-6. doi: 10.1210/jc.2004-1959. Epub 2005 Mar 15.
- Background Mahmood S, Taketa K, Imai K, Kajihara Y, Imai S, Yokobayashi T, Yamamoto S, Sato M, Omori H, Manabe K. Association of fatty liver with increased ratio of visceral to subcutaneous adipose tissue in obese men. Acta Med Okayama. 1998 Aug;52(4):225-31. doi: 10.18926/AMO/31297.
- Background Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.
- Background Hall KD. Predicting metabolic adaptation, body weight change, and energy intake in humans. Am J Physiol Endocrinol Metab. 2010 Mar;298(3):E449-66. doi: 10.1152/ajpendo.00559.2009. Epub 2009 Nov 24.
- Background Wells GD, Noseworthy MD, Hamilton J, Tarnopolski M, Tein I. Skeletal muscle metabolic dysfunction in obesity and metabolic syndrome. Can J Neurol Sci. 2008 Mar;35(1):31-40. doi: 10.1017/s0317167100007538.
- Background Bergman RN, Ider YZ, Bowden CR, Cobelli C. Quantitative estimation of insulin sensitivity. Am J Physiol. 1979 Jun;236(6):E667-77. doi: 10.1152/ajpendo.1979.236.6.E667.
- Background Elia M, Livesey G. Energy expenditure and fuel selection in biological systems: the theory and practice of calculations based on indirect calorimetry and tracer methods. World Rev Nutr Diet. 1992;70:68-131. doi: 10.1159/000421672. No abstract available.
- Whytock KL, Corbin KD, Parsons SA, Pachori A, Bock CP, Jones KP, Smith JS, Yi F, Xie H, Petucci CJ, Gardell SJ, Smith SR. Metabolic adaptation characterizes short-term resistance to weight loss induced by a low-calorie diet in overweight/obese individuals. Am J Clin Nutr. 2021 Jul 1;114(1):267-280. doi: 10.1093/ajcn/nqab027.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Phentermine | Small molecule | — | — |