Investigation of Neuro-hormonal Mechanisms of Hunger, Fullness and Obesity. - Full Text View

Purpose

The purpose of this study is to determine abnormal neuro-hormonal mechanisms that may impair the ability to feel full and which therefore, may lead to obesity.

Condition
Obesity Gastric Emptying Anxiety Depression Panic Disorder

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Obesity Panic Disorder

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Cholecystokinin serum level [ Time Frame: fasting- state, then at time points 30, 60 and 120 minutes post-meal ] [ Designated as safety issue: No ]
Oxytocin serum bioassay [ Time Frame: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal ] [ Designated as safety issue: No ]
Gastric Emptying time [ Time Frame: calculated at time points 0.5, 1,2,3 and 4 hours post-meal ] [ Designated as safety issue: No ]
Perception of fullness using visual analog scales [ Time Frame: fasting-state, and then at time points of every half hour post-meal through completion of the scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mini International Neuro-psychiatric Interview (MINI) [ Time Frame: once within 30 days of the scan ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	October 2009
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Obese Healthy obese subjects
Non-obese Healthy non-obese subjects

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Community sample, patients of a weight management clinic and patients of Medical University of South Carolina

Criteria

Inclusion Criteria:

Males and females 18 to 65 years of age.
Obese Subjects with BMI >40.
Normal weight subjects with BMI = 18.5-24.9

Exclusion Criteria:

Age younger than 18 years and over 65 years of age.
Current use of narcotics or morphine
Previous gastric surgery
Presence of the following disorders that are known to cause functional gastric stasis syndromes: Diabetes Mellitus, Hypothyroidism, Progressive Systemic Sclerosis, Systemic Lupus Erythematosus, Dermatomyositis, Familial Dysautonomia, Pernicious Anemia, Bulbar poliomyelitis, Amyloidosis, Gastric Ulcer, Post-vagotomy, Tumor-associated gastroparesis, Fabry disease, Myotonic Dystrophy, Post-operative ileus, Gastroenteritis.
Presence of the following disorders that are known to cause delayed gastric emptying: peptic ulceration, recent surgery, pyloric hypertrophy, post-radiotherapy, ileus, anorexia nervosa, acute viral infections.
Presence of the following disorders that are known to cause rapid gastric emptying: Pyloroplasty, Hemigastrectomy, Duodenal ulcer, Gastrinoma (Zollinger-Ellison syndrome), Hyperthyroidism
Current use of Thyroxine as it is known to cause rapid gastric emptying
Current or recent (within the last 2 weeks) use of anti-spasmodics or pro-kinetic medications.
Current use of Hyperalimentation
Presence of any metabolic disorder, such as: hyperglycemia, acidosis, hypokalemia, hypercalcemia, hepatic coma or myxedema.
Current use of estrogen or progesterone
Current use of the following drugs that are known to delay gastric emptying: Nifedipine, beta-adrenergic agonists, Isoproterenol, Theophylline, Sucralfate, anticholinergics, Levodopa, diazepam, tricyclic antidepressants, phenothiazine, Progesterone, oral contraceptives, alcohol, nicotine, opiates.
Allergy to eggs or wheat.
Pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008371

Locations

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403

Sponsors and Collaborators

Medical University of South Carolina

National Institutes of Health (NIH)

Society of Nuclear Medicine

Investigators

Principal Investigator:	Kelly A Holes-Lewis, M.D.	Medical University of South Carolina
Study Chair:	Thomas W Uhde, M.D.	Medical University of South Carolina

More Information

Publications:

Flegal KM, Graubard BI, Williamson DF, Gail MH. Cause-specific excess deaths associated with underweight, overweight, and obesity. JAMA. 2007 Nov 7;298(17):2028-37.

[No authors listed] Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults: executive summary. Expert Panel on the Identification, Evaluation, and Treatment of Overweight in Adults. Am J Clin Nutr. 1998 Oct;68(4):899-917. No abstract available.

Valassi E, Scacchi M, Cavagnini F. Neuroendocrine control of food intake. Nutr Metab Cardiovasc Dis. 2008 Feb;18(2):158-68. Epub 2007 Dec 3. Review.

Burton-Freeman B, Davis PA, Schneeman BO. Plasma cholecystokinin is associated with subjective measures of satiety in women. Am J Clin Nutr. 2002 Sep;76(3):659-67.

Konturek SJ, Konturek JW, Pawlik T, Brzozowski T. Brain-gut axis and its role in the control of food intake. J Physiol Pharmacol. 2004 Mar;55(1 Pt 2):137-54. Review.

Rehfeld JF. Accurate measurement of cholecystokinin in plasma. Clin Chem. 1998 May;44(5):991-1001.

Liddle RA, Morita ET, Conrad CK, Williams JA. Regulation of gastric emptying in humans by cholecystokinin. J Clin Invest. 1986 Mar;77(3):992-6.

McCann UD, Slate SO, Geraci M, Roscow-Terrill D, Uhde TW. A comparison of the effects of intravenous pentagastrin on patients with social phobia, panic disorder and healthy controls. Neuropsychopharmacology. 1997 Mar;16(3):229-37.

Zhang W, Gardell S, Zhang D, Xie JY, Agnes RS, Badghisi H, Hruby VJ, Rance N, Ossipov MH, Vanderah TW, Porreca F, Lai J. Neuropathic pain is maintained by brainstem neurons co-expressing opioid and cholecystokinin receptors. Brain. 2009 Mar;132(Pt 3):778-87. Epub 2008 Dec 2.

Moran TH, Dailey MJ. Minireview: Gut peptides: targets for antiobesity drug development? Endocrinology. 2009 Jun;150(6):2526-30. Epub 2009 Apr 16. Review.

Konturek PC, Konturek JW, Cze?nikiewicz-Guzik M, Brzozowski T, Sito E, Konturek SJ. Neuro-hormonal control of food intake: basic mechanisms and clinical implications. J Physiol Pharmacol. 2005 Dec;56 Suppl 6:5-25. Review.

Little TJ, Russo A, Meyer JH, Horowitz M, Smyth DR, Bellon M, Wishart JM, Jones KL, Feinle-Bisset C. Free fatty acids have more potent effects on gastric emptying, gut hormones, and appetite than triacylglycerides. Gastroenterology. 2007 Oct;133(4):1124-31. Epub 2007 Jul 3.

Monstein HJ, Grahn N, Truedsson M, Ohlsson B. Oxytocin and oxytocin-receptor mRNA expression in the human gastrointestinal tract: a polymerase chain reaction study. Regul Pept. 2004 Jun 15;119(1-2):39-44.

Ohlsson B, Forsling ML, Rehfeld JF, Sjölund K. Cholecystokinin stimulation leads to increased oxytocin secretion in women. Eur J Surg. 2002;168(2):114-8.

Borg J, Melander O, Johansson L, Uvnäs-Moberg K, Rehfeld JF, Ohlsson B. Gastroparesis is associated with oxytocin deficiency, oesophageal dysmotility with hyperCCKemia, and autonomic neuropathy with hypergastrinemia. BMC Gastroenterol. 2009 Feb 25;9:17.

Runge CF. Economic consequences of the obese. Diabetes. 2007 Nov;56(11):2668-72. Epub 2007 Jun 29. Review.

Dall TM, Fulgoni VL 3rd, Zhang Y, Reimers KJ, Packard PT, Astwood JD. Potential health benefits and medical cost savings from calorie, sodium, and saturated fat reductions in the American diet. Am J Health Promot. 2009 Jul-Aug;23(6):412-22.

Zwirska-Korczala K, Konturek SJ, Sodowski M, Wylezol M, Kuka D, Sowa P, Adamczyk-Sowa M, Kukla M, Berdowska A, Rehfeld JF, Bielanski W, Brzozowski T. Basal and postprandial plasma levels of PYY, ghrelin, cholecystokinin, gastrin and insulin in women with moderate and morbid obesity and metabolic syndrome. J Physiol Pharmacol. 2007 Mar;58 Suppl 1:13-35.

Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. Epub 2008 Feb 20.

Responsible Party:	Kelly Holes-Lewis, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT01008371 History of Changes
Other Study ID Numbers:	19449
Study First Received:	November 3, 2009
Last Updated:	May 21, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

Obesity
Cholecystokinin
Oxytocin
Satiety

Gastric emptying
Anxiety
Depression
Panic Disorder

Additional relevant MeSH terms:

Anxiety Disorders
Depression
Depressive Disorder
Obesity
Panic Disorder
Mental Disorders
Behavioral Symptoms

Mood Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013