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Trial · Observational

WithdrawnPhase not statedRegistry data

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

NCTNCT01008371 (opens ClinicalTrials.gov in a new tab)Other id19449
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Oxytocin, does not give it. It appears in an outcome measure.

Overview

Status
Withdrawn
Phase
Phase not stated
Enrollment
0 participants (actual)
Sponsor
Medical University of South Carolina · Other
Design
Not stated
Countries
1 country

United States

Start
Oct 2009
Primary completion
Mar 2013
Completion
Mar 2013
First posted
5 Nov 2009 (estimated)
Last update posted
22 May 2013 (estimated)
Conditions
Obesity · Gastric Emptying · Anxiety · Depression · Panic Disorder

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011201220132014
  1. Ph –

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

    NCT01008371

    Oct 2009 to Mar 2013

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Arms2

  • Other

    Obese

    Healthy obese subjects

  • Other

    Non-obese

    Healthy non-obese subjects

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Cholecystokinin serum level

    Time frame · fasting- state, then at time points 30, 60 and 120 minutes post-meal

  2. Oxytocin serum bioassay

    Time frame · fasting-state, and then at time points of 30, 60 and 120 minutes post-meal

  3. Gastric Emptying time

    Time frame · calculated at time points 0.5, 1,2,3 and 4 hours post-meal

  4. 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

Secondary outcomes(1)

  1. Mini International Neuro-psychiatric Interview (MINI)

    Time frame · once within 30 days of the scan

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2002

5 results

Cholecystokinin stimulation leads to increased oxytocin secretion in women.

Ohlsson et al. 2002The European journal of surgery = Acta chirurgicacited by 42

PMID 12113268DOI 10.1080/11024150252884340PUB-12113268

Rights unknown5 results
Source linkSee results (5)

More studies

3 studies on this page

PubMed tag: none · 2009

Gastroparesis is associated with oxytocin deficiency, oesophageal dysmotility with hyperCCKemia, and autonomic neuropathy with hypergastrinemia.

Borg et al. 2009BMC gastroenterologycited by 23

PMID 19243587PMC2650701DOI 10.1186/1471-230x-9-17PUB-19243587

CC BY
Download PDF

Indexing hint: Review · 2008

Neuroendocrine control of food intake.

Valassi et al. 2008Nutrition, metabolism, and cardiovascular diseases : NMCDcited by 451

PMID 18061414DOI 10.1016/j.numecd.2007.06.004PUB-18061414

Full text at the publisher
Publisher page

PubMed tag: none · 2004

Oxytocin and oxytocin-receptor mRNA expression in the human gastrointestinal tract: a polymerase chain reaction study.

Monstein et al. 2004Regulatory peptidescited by 70

PMID 15093695DOI 10.1016/j.regpep.2003.12.017PUB-15093695

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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