Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients
1 other identifier
observational
40
1 country
1
Brief Summary
The mechanisms that regulate appetite in the morbidly obese are multifactorial and not well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an important role in the central regulation of appetite and hunger. Postprandial ghrelin and cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an effect on satiety sensation. On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also promotes changes in gastric emptying which are not clearly defined. Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and satiety in morbidly obese individuals, especially those related with gallbladder and gastric emptying, as well as those related with the response of the gastrointestinal hormones ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A) non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test after a fasting night will be administered and appetite, satiety and hormonal response (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol absorption technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedApril 13, 2015
April 1, 2015
2.8 years
March 25, 2015
April 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hunger and satiety assessment by Visual Analogic Scale
4 hours
Secondary Outcomes (6)
Gastric emptying differences between groups measured by paracetamol absorption test
4 hours
Gallbladder volume differences between groups measured by ultrasonography
4 hours
Ghrelin level differences between groups
4 hours
CCK level differences between groups
4 hours
GLP-1 level differences between groups
4 hours
- +1 more secondary outcomes
Study Arms (3)
Non obese
Morbidly obese
Sleeve gastrectomy
Interventions
Laparoscopic vertical gastrectomy as a bariatric procedure.
Eligibility Criteria
Group A: non obese healthy individuals Group B: morbidly obese individuals Group C: individuals who had had a previous sleeve gastrectomy as a bariatric procedures
You may qualify if:
- Group A: non obese individuals (Body Mass Index; BMI \< 30 Kg/m2) Group B: Fulfilling the National Health Institute (NHI) criteria for bariatric surgery (BMI higher than 40 Kg/m2 or 35 Kg/m2 when related comorbidities) Group C: Previous morbidly obese individuals who had had a sleeve gastrectomy at least 6 months ago.
You may not qualify if:
- Group A: previous gastric surgery or gallbladder removal. Group B: previous gastric surgery or gallbladder removal. Group C: previous gallbladder removal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari del Maresme
Mataró, Barcelona, 08304, Spain
Related Publications (1)
Mans E, Serra-Prat M, Palomera E, Sunol X, Clave P. Sleeve gastrectomy effects on hunger, satiation, and gastrointestinal hormone and motility responses after a liquid meal test. Am J Clin Nutr. 2015 Sep;102(3):540-7. doi: 10.3945/ajcn.114.104307. Epub 2015 Jul 22.
PMID: 26201818DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2015
First Posted
April 13, 2015
Study Start
September 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
April 13, 2015
Record last verified: 2015-04