Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)
NCT ID: NCT01616082
Last Updated: 2020-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2011-09-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Overwight/Obese with no drug
After screening, overweight/obese subjects (BMI \>27 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved.
Low Calorie Diet (LCD)
A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.
Overweight/obese with Phentermine
After screening, overweight/obese (BMI \>27.0 - ≤40.0) subjects will be started on a low calorie diet (approximately 900-1000 kcal/d) until a target weight loss is achieved. Individuals not on track to achieve their target weight by four weeks will receive the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects will be given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Low Calorie Diet (LCD)
A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.
Phentermine
Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Protection Against Risk:
* Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication.
* Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated.
Interventions
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Low Calorie Diet (LCD)
A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.
Phentermine
Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Protection Against Risk:
* Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication.
* Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated.
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) 27-30 kg/m2, inclusive, with hypertension, controlled (\<140 / \<90) either by diet or medication.
* BMI 30-40 kg/m2, inclusive.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
* Known hypersensitivity to phentermine, lidocaine, bupivicaine or any medication component of the study procedure.
* Presence of cardiac pacemaker, implanted cardiac defibrillator, or brain aneurysm clips.
* Any significant bleeding diathesis which could preclude recovery from the biopsy procedure. ASA, ibuprofen, and any other oral anti platelet agent will be discontinued at least 7 days prior to procedure.
* Abnormal CK as per site laboratory ranges.
* Subjects with either a medical history of or physical evidence of keloid scar formation upon physical examination.
* 12-lead electrocardiogram (ECG) demonstrating a clinically significant abnormality.
* Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection.
* Participation in non-routine rigorous exercise (e.g., road races, heavy lifting, etc.) within one week prior to the muscle biopsy procedures.
* Presence of any condition in the investigator's opinion that may negatively affect subject safety or protocol adherence.
* Females of childbearing potential (any female except those with tubal ligation, hysterectomy, or absence of menses \> 2years) unwilling to use an approved method of contraception (condom, diaphragm, implantable uterine device (IUD) that does not release hormones).
* Prior participation in the Magellan I study at the Translational Research Institute for Metabolism and Diabetes.
18 Years
55 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
AdventHealth Translational Research Institute
OTHER
Responsible Party
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Principal Investigators
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Steven R Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Translational Research Institute for Metabolism and Diabetes
Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Translational Research Institute for Metabolism and Diabetes web page for more information on the study
Other Identifiers
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266040
Identifier Type: OTHER
Identifier Source: secondary_id
TRIMDFH 266040
Identifier Type: -
Identifier Source: org_study_id