Residual Gastric Volume in Morbidly Obesa Diabetics. A Comparison of 3 Hour Versus Hour Fasting.

NCT02114008 | Completed DMC

• 1 other identifier: 179.017/2012 CEP UFMT
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

To reduce the risk of aspiration for elective procedures, residual gastric volumes (RGV) have traditionally been minimized with overnight fasting. However, prolonged fasting can also have some adverse consequences and has been abandoned for some procedures in several patient populations with the exception of obese and/or diabetic patients. The aim of this study was to assess RGV in morbidly obese diabetic patients after traditional or abbreviated fasting.

Conditions

Obesity; Diabetes; Fasting

Keywords

Gastric emptying.; Residual gastric volume.; Preoperative fasting.; Morbid Obesity.; Diabetes.

Outcome Measures

Primary Outcomes (1)

• Residual gastric volume (RGV) in morbidly obese diabetics. A comparison of 3 hour versus 8 hour fasting

  This was a prospective, randomized, double-blind, and cross-over design in 8 morbidly obese type II diabetics with informed consent. RGV was measured endoscopically after three and eight hour fasts.

  3 months

Study Arms (2)

Abbreviated fasting

ACTIVE COMPARATOR

Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin).

Other: Endoscopic examinations

Traditional fasting

ACTIVE COMPARATOR

Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test).

Other: Endoscopic examinations

Interventions

Endoscopic examinations OTHER

Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.

Abbreviated fasting; Traditional fasting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Cuiaba University: lead

Study Sites (1)

Gunther Peres Pimenta

Cuiabá, Mato Grosso, 78040500, Brazil

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Fasting; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Study Officials

• Gunther P Pimenta, MD, PhD

  Cuiaba University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 12, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

BR (1)