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ObesityNCT01008371

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

An observational study of Obesity and Gastric Emptying, run by Medical University of South Carolina at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Gastric Emptying, Anxiety
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2009to Mar 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29403

Other trials in United States

About this study

Official title: CCK-dysregulation: Mechanisms of Abnormal Food Regulation and Obesity

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.

Keywords
Obesity, Cholecystokinin, Oxytocin, Satiety, Gastric emptying, Anxiety, Depression, Panic Disorder
Medical subject headings
Obesity, Anxiety Disorders, Depression, Panic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01008371
Study groupRoleWhat they receive
ObeseHealthy obese subjects
Non-obeseHealthy non-obese subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cholecystokinin serum level

    Measured: fasting- state, then at time points 30, 60 and 120 minutes post-meal

  2. Oxytocin serum bioassay

    Measured: fasting-state, and then at time points of 30, 60 and 120 minutes post-meal

  3. Gastric Emptying time

    Measured: calculated at time points 0.5, 1,2,3 and 4 hours post-meal

  4. Perception of fullness using visual analog scales

    Measured: fasting-state, and then at time points of every half hour post-meal through completion of the scan

Secondary outcomes (1)

  1. Mini International Neuro-psychiatric Interview (MINI)

    Measured: once within 30 days of the scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionMar 2013
  4. Study completionMar 2013

Why it stopped: No recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008371
Sponsor's protocol ID
19449
Status last verified
Jul 2010
First submitted
3 Nov 2009
Last updated
22 May 2013
Results posted
No
Data monitoring committee
No

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. doi: 10.1001/jama.298.17.2028.

    PubMed 17986696

  • 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. doi: 10.1093/ajcn/68.4.899. No abstract available.

    PubMed 9771869

  • Valassi E, Scacchi M, Cavagnini F. Neuroendocrine control of food intake. Nutr Metab Cardiovasc Dis. 2008 Feb;18(2):158-68. doi: 10.1016/j.numecd.2007.06.004. Epub 2007 Dec 3.

    PubMed 18061414

  • 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. doi: 10.1093/ajcn/76.3.659.

    PubMed 12198015

  • 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.

    PubMed 15082874

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

    PubMed 9590372

  • 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. doi: 10.1172/JCI112401.

    PubMed 3949984

  • 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. doi: 10.1016/S0893-133X(96)00197-2.

    PubMed 9138439

  • 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.

    PubMed 19050032

  • 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.

    PubMed 19372201

  • 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.

    PubMed 16340035

  • 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. doi: 10.1053/j.gastro.2007.06.060. Epub 2007 Jul 3.

    PubMed 17919488

  • 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. doi: 10.1016/j.regpep.2003.12.017.

    PubMed 15093695

  • Ohlsson B, Forsling ML, Rehfeld JF, Sjolund K. Cholecystokinin stimulation leads to increased oxytocin secretion in women. Eur J Surg. 2002;168(2):114-8. doi: 10.1080/11024150252884340.

    PubMed 12113268

  • Borg J, Melander O, Johansson L, Uvnas-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.

    PubMed 19243587

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Gastric Emptying, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cholecystokinin serum level (time frame: fasting- state, then at time points 30, 60 and 120 minutes post-meal). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01008371, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.

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