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| ID | Type | Description | Link |
|---|---|---|---|
| 266040 | Other Identifier | Florida Hospital IRB |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
In this study the investigators will examine the hypothesis that overweight/obese individuals that are unable to meet target weight loss goals on a low calorie diet (LCD) are intrinsically less metabolically flexible than their weight-losing counterparts. The investigators expect that this 'inflexibility' will be characterized by impaired fat oxidation (as determined by indirect calorimetry) in response to caloric restriction. If this were the case, these subjects may represent a population of 'super-responders' likely to demonstrate a robust response to approaches to increase fat oxidation. The investigators will also measure lipid concentrations in skeletal muscle and liver by hydrogen 1 magnetic resonance (1H-MRS) to determine both the stability of these measurements as well as the magnitude of changes that can be seen during LCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overwight/Obese with no drug | Active Comparator | 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. |
|
| Overweight/obese with Phentermine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Calorie Diet (LCD) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Amount of Fat Oxidation at 14 Days | Measured with respiratory quotient obtained with indirect calorimetry Expected Results
| Days 0, 14 |
| Fat Oxidation Rates at 1 Week Intervals | Measured with respiratory quotient using indirect calorimetry Expected Results
| Days 0, 7, 14, 28, 49, 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Soleus IMCL Content | Measured with magnetic resonance spectroscopy (MRS) Expected results
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Smith, MD | Translational Research Institute for Metabolism and Diabetes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19056573 | 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. | |
| 9216960 | 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. |
| Label | URL |
|---|---|
| Translational Research Institute for Metabolism and Diabetes web page for more information on the study | View source |
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Overweight/obese participant were recruited to the study to participate in a 28 day low calorie diet (LCD). After 28 days, participants were evaluated for whether they met their expected weight loss targets. If participants met their targets they continued the LCD for a further 28 days and are defined as Overweight/Obese With no Drug. If participants did not reach their weight loss target they continued with LCD with an addition of phentermine and are defined as Overweight/Obese With Phentermine
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| ID | Title | Description |
|---|---|---|
| FG000 | Overweight/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 will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period= continuous for 8 weeks. |
| FG001 | 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 will be completed, and the subjects will have dietary counseling and be provided shakes. LCD period = continuous for 8 weeks. Phentermine: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ovweight/Obese With no Drug | After screening, overweight (obese subjects (BMI >27 - ≤40.0) subjects (n=35) 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 will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Amount of Fat Oxidation at 14 Days | Measured with respiratory quotient obtained with indirect calorimetry Expected Results
| Posted | Mean | Standard Deviation | Fold change of RQ ratio | Days 0, 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overweight/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 will be completed, and the subjects will have dietary counseling and be provided shakes. The low calorie diet will begin, to continue for a period of 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven R. Smith | Translational Research Institute for Metabolism and Diabetes | 407-303-7115 | steven.r.smith.md@flhosp.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Phentermine | Drug | 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:
|
|
| Days -7, -1, 14, 56 |
| 17327442 | 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. |
| 2240203 | 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. |
| 18177724 | 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. |
| 21632903 | 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. |
| 15755861 | 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. |
| 10027589 | 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. |
| 20048484 | 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. |
| 10102702 | 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. |
| 18078853 | 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. |
| 15769987 | 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. |
| 9781273 | 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. |
| 16756727 | 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. |
| 19934407 | 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. |
| 18380275 | 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. |
| 443421 | 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. |
| 1292242 | 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. |
| 33826697 | Derived | 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. |
| BG001 | Overweigh/Obese With Phentermine | After screening, 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. 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): See prior information. Phentermine: See prior information. Protection Against Risk: See prior information. . |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Overweight/ Obese With Phentermine | After screening, 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. 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): See prior information. Phentermine: See prior information. Protection Against Risk: See prior information. . |
|
|
| Primary | Fat Oxidation Rates at 1 Week Intervals | Measured with respiratory quotient using indirect calorimetry Expected Results
| Posted | Mean | Standard Deviation | Ratio | Days 0, 7, 14, 28, 49, 56 |
|
|
|
| Secondary | Soleus IMCL Content | Measured with magnetic resonance spectroscopy (MRS) Expected results
| Posted | Mean | Standard Deviation | ratio of peak height of IMCL to water | Days -7, -1, 14, 56 |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Overwight/Obese With Phentermine | After screening, 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. 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) Phentermine | 0 | 20 | 0 | 20 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| Day 14 |
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| Day 28 |
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| Day 49 |
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| Day 56 |
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| Day 14 |
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| Day 56 |
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