Hunger/Satiety's Physiopathologic Study in Morbidly Obese... | NCT02414893

Studies
Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

NCT02414893

Sponsor

Consorci Sanitari del Maresme

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Morbid Obesity

Interventions

Sleeve gastrectomy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Apr 10, 2015

First Posted Date

Apr 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non obese
Morbidly obese
Sleeve gastrectomy			Procedure: Sleeve gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleeve gastrectomy	Procedure	Laparoscopic vertical gastrectomy as a bariatric procedure.	Sleeve gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hunger and satiety assessment by Visual Analogic Scale		4 hours

Secondary Outcomes

Measure	Description	Time Frame
Gastric emptying differences between groups measured by paracetamol absorption test		4 hours
Gallbladder volume differences between groups measured by ultrasonography		4 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consorci Sanitari del Maresme		Mataró	Barcelona	08304	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26201818	Derived	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.

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders