Skip to main content
OpenTrials
Completed

NCT Number: NCT02414893

Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Group A: previous gastric surgery or gallbladder removal. Group B: previous gastric surgery or gallbladder removal. Group C: previous gallbladder removal.

Treatment and study plan

Sleeve gastrectomy

Procedure

Laparoscopic vertical gastrectomy as a bariatric procedure.

Primary outcomes

  1. Hunger and satiety assessment by Visual Analogic Scale

    Time frame: 4 hours

Secondary outcomes

  1. Gastric emptying differences between groups measured by paracetamol absorption test

    Time frame: 4 hours

  2. Gallbladder volume differences between groups measured by ultrasonography

    Time frame: 4 hours

  3. Ghrelin level differences between groups

    Time frame: 4 hours

  4. CCK level differences between groups

    Time frame: 4 hours

  5. GLP-1 level differences between groups

    Time frame: 4 hours

  6. Glucose homeostasis differences between groups

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Official study title

Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients: Relation Between Hunger/Satiety, Gastric Emptying, Gallbladder Motility and Peripheral Neurohormonal Signs

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2015
Registry last updated
Apr 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.