Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
96 participants
INTERVENTIONAL
2007-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Obese subjects with BED
Subjects who meet the BMI requirement for obesity (\>30 kg/m\^2) and the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Test meal
Subjects are presented with an ad libitum buffet meal.
Obese without BED
Subjects who meet the BMI requirement for obesity (\>30 kg/m\^2) but who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Test meal
Subjects are presented with an ad libitum buffet meal.
Normal-weight without BED
Subjects with BMI 20-25 kg/m\^2 who do not meet the DSM requirements for binge eating disorder based on responses to validated questionnaires.
Subjects will undergo the postprandial responses, cold pressor test and ad libitum test meal.
Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Test meal
Subjects are presented with an ad libitum buffet meal.
Interventions
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Postprandial responses
Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
Cold pressor test
Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
Test meal
Subjects are presented with an ad libitum buffet meal.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* stable weight(± 4%) for at least 3 mo
* premenopausal and have regular menstrual cycles (28 d ± 5), not be pregnant or lactating, and not be within 1 y of childbirth
* must like pizza and be willing to consume it during the ad libitum meal
Exclusion Criteria
* current and past 3-mo use of certain prescribed medications, especially those that could affect body weight, such as antidepressants and stimulants as well as smoking, or excess alcohol (\> 3 drinks/d)
* vigorously exercise for more than 6 h/wk
* left-handed, with known claustrophobia for a scanner enclosure, or have metal implants, non-removable metallic dental retainers, pacemakers, or permanent eyeliner or large tattoos that contain metallic pigment
18 Years
50 Years
ALL
Yes
Sponsors
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St. Luke's-Roosevelt Hospital Center
OTHER
Columbia University
OTHER
New York Obesity and Nutrition Research Center
OTHER
Responsible Party
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Dr. Allan Geliebter
Principal Investigator
Principal Investigators
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Allan Geliebter, PhD
Role: PRINCIPAL_INVESTIGATOR
New York Obesity and Nutrition Research Center
Locations
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St. Luke's Hospital
New York, New York, United States
Countries
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References
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de Zwaan M, Mitchell JE, Raymond NC, Spitzer RL. Binge eating disorder: clinical features and treatment of a new diagnosis. Harv Rev Psychiatry. 1994 Mar-Apr;1(6):310-25. doi: 10.3109/10673229409017098.
Hellstrom PM, Geliebter A, Naslund E, Schmidt PT, Yahav EK, Hashim SA, Yeomans MR. Peripheral and central signals in the control of eating in normal, obese and binge-eating human subjects. Br J Nutr. 2004 Aug;92 Suppl 1:S47-57. doi: 10.1079/bjn20041142.
Cowley MA, Smith RG, Diano S, Tschop M, Pronchuk N, Grove KL, Strasburger CJ, Bidlingmaier M, Esterman M, Heiman ML, Garcia-Segura LM, Nillni EA, Mendez P, Low MJ, Sotonyi P, Friedman JM, Liu H, Pinto S, Colmers WF, Cone RD, Horvath TL. The distribution and mechanism of action of ghrelin in the CNS demonstrates a novel hypothalamic circuit regulating energy homeostasis. Neuron. 2003 Feb 20;37(4):649-61. doi: 10.1016/s0896-6273(03)00063-1.
Batterham RL, Cohen MA, Ellis SM, Le Roux CW, Withers DJ, Frost GS, Ghatei MA, Bloom SR. Inhibition of food intake in obese subjects by peptide YY3-36. N Engl J Med. 2003 Sep 4;349(10):941-8. doi: 10.1056/NEJMoa030204.
English PJ, Ghatei MA, Malik IA, Bloom SR, Wilding JP. Food fails to suppress ghrelin levels in obese humans. J Clin Endocrinol Metab. 2002 Jun;87(6):2984. doi: 10.1210/jcem.87.6.8738.
Monteleone P, Martiadis V, Rigamonti AE, Fabrazzo M, Giordani C, Muller EE, Maj M. Investigation of peptide YY and ghrelin responses to a test meal in bulimia nervosa. Biol Psychiatry. 2005 Apr 15;57(8):926-31. doi: 10.1016/j.biopsych.2005.01.004.
Monteleone P, Martiadis V, Fabrazzo M, Serritella C, Maj M. Ghrelin and leptin responses to food ingestion in bulimia nervosa: implications for binge-eating and compensatory behaviours. Psychol Med. 2003 Nov;33(8):1387-94. doi: 10.1017/s0033291703008316.
Geliebter A, Yahav EK, Gluck ME, Hashim SA. Gastric capacity, test meal intake, and appetitive hormones in binge eating disorder. Physiol Behav. 2004 Jul;81(5):735-40. doi: 10.1016/j.physbeh.2004.04.014.
Geliebter A, Gluck ME, Hashim SA. Plasma ghrelin concentrations are lower in binge-eating disorder. J Nutr. 2005 May;135(5):1326-30. doi: 10.1093/jn/135.5.1326.
Raymond NC, Neumeyer B, Warren CS, Lee SS, Peterson CB. Energy intake patterns in obese women with binge eating disorder. Obes Res. 2003 Jul;11(7):869-79. doi: 10.1038/oby.2003.120.
Walsh BT, Boudreau G. Laboratory studies of binge eating disorder. Int J Eat Disord. 2003;34 Suppl:S30-8. doi: 10.1002/eat.10203.
Anderson DA, Williamson DA, Johnson WG, Grieve CO. Validity of test meals for determining binge eating. Eat Behav. 2001 Summer;2(2):105-12. doi: 10.1016/s1471-0153(01)00022-8.
Geliebter A, Melton PM, McCray RS, Gallagher DR, Gage D, Hashim SA. Gastric capacity, gastric emptying, and test-meal intake in normal and bulimic women. Am J Clin Nutr. 1992 Oct;56(4):656-61. doi: 10.1093/ajcn/56.4.656.
Geliebter A, Hassid G, Hashim SA. Test meal intake in obese binge eaters in relation to mood and gender. Int J Eat Disord. 2001 May;29(4):488-94. doi: 10.1002/eat.1047.
Tataranni PA, Larson DE, Snitker S, Young JB, Flatt JP, Ravussin E. Effects of glucocorticoids on energy metabolism and food intake in humans. Am J Physiol. 1996 Aug;271(2 Pt 1):E317-25. doi: 10.1152/ajpendo.1996.271.2.E317.
Castonguay TW. Glucocorticoids as modulators in the control of feeding. Brain Res Bull. 1991 Sep-Oct;27(3-4):423-8. doi: 10.1016/0361-9230(91)90136-8.
Epel E, Lapidus R, McEwen B, Brownell K. Stress may add bite to appetite in women: a laboratory study of stress-induced cortisol and eating behavior. Psychoneuroendocrinology. 2001 Jan;26(1):37-49. doi: 10.1016/s0306-4530(00)00035-4.
Koo-Loeb JH, Costello N, Light KC, Girdler SS. Women with eating disorder tendencies display altered cardiovascular, neuroendocrine, and psychosocial profiles. Psychosom Med. 2000 Jul-Aug;62(4):539-48. doi: 10.1097/00006842-200007000-00013.
Kelly CB, Cooper SJ. Plasma norepinephrine response to a cold pressor test in subtypes of depressive illness. Psychiatry Res. 1998 Oct 19;81(1):39-50. doi: 10.1016/s0165-1781(98)00086-9.
Gluck ME, Geliebter A, Hung J, Yahav E. Cortisol, hunger, and desire to binge eat following a cold stress test in obese women with binge eating disorder. Psychosom Med. 2004 Nov-Dec;66(6):876-81. doi: 10.1097/01.psy.0000143637.63508.47.
Yanovski SZ. Binge eating disorder: current knowledge and future directions. Obes Res. 1993 Jul;1(4):306-24. doi: 10.1002/j.1550-8528.1993.tb00626.x.
Geliebter A, Ladell T, Logan M, Schneider T, Sharafi M, Hirsch J. Responsivity to food stimuli in obese and lean binge eaters using functional MRI. Appetite. 2006 Jan;46(1):31-5. doi: 10.1016/j.appet.2005.09.002. Epub 2005 Dec 20.
Related Links
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New York Obesity and Nutrition Research Center
Other Identifiers
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06-163
Identifier Type: -
Identifier Source: org_study_id
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