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

Obesity Clinical Trial

Official title:

CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01008371
• Other study ID #: 19449
• Status: Withdrawn
• Phase: N/A
• First received: November 3, 2009
• Last updated: May 21, 2013
• Start date: October 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Anxiety
• Depression
• Gastric Emptying
• Obesity
• Panic Disorder

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institutes of Health (NIH), Society of Nuclear Medicine

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20. — View Citation

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. doi: 10.1186/1471-230X-9-17. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.4278/ajhp.080930-QUAN-226. — View Citation

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. — View Citation

Konturek PC, Konturek JW, Czesnikiewicz-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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Moran TH, Dailey MJ. Minireview: Gut peptides: targets for antiobesity drug development? Endocrinology. 2009 Jun;150(6):2526-30. doi: 10.1210/en.2009-0003. Epub 2009 Apr 16. Review. — View Citation

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. — View Citation

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

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

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. — View Citation

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. doi: 10.1093/brain/awn330. Epub 2008 Dec 2. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cholecystokinin serum level		fasting- state, then at time points 30, 60 and 120 minutes post-meal	No
Primary	Oxytocin serum bioassay		fasting-state, and then at time points of 30, 60 and 120 minutes post-meal	No
Primary	Gastric Emptying time		calculated at time points 0.5, 1,2,3 and 4 hours post-meal	No
Primary	Perception of fullness using visual analog scales		fasting-state, and then at time points of every half hour post-meal through completion of the scan	No
Secondary	Mini International Neuro-psychiatric Interview (MINI)		once within 30 days of the scan	No