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NCT Number: NCT03217630

Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls

This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
  • age≥18 yr; ASA physical status I-III;
  • body mass index <35kg/m2;
  • who are admitted to the surgical department;
  • who are able to understand the rationale of the study and provide informed consent.

Exclusion criteria

  • pregnancy;
  • a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
  • documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
  • recent upper gastrointestinal bleeding (within the preceding 1 month);
  • taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
  • hypothyroidism.

Treatment and study plan

Fasting 2 h after clear liquid or 6h after a light meal

Other

The fasting time for all patients is 2 h after clear liquid or 6h after a light meal, then gastric ultrasound examination is performed.

Primary outcomes

  1. Prevalence of full stomach

    Time frame: one day

    The frequency of a "full stomach" in the diabetic population compared to a non-diabetic control population at 2h after ingesting clear liquid or 6h after light meal.

Secondary outcomes

  1. Mean gastric emptying time of clear liquid and light meal

    Time frame: one day

    The mean gastric emptying time of clear liquid and light meal in both diabetic and non-diabetic population.

Other outcomes

  1. Risk factors of delayed stomach empty in diabetic patients

    Time frame: one day

    Correlation between the latest fast, postprandial plasma glucose concentration, hemoglobin A1c level and the diabetes complications ( peripheral neuropathy, cardiovascular autonomic neuropathy, diabetic nephropathy,and diabetes mellitus-related eye disease (including diabetic retinopathy, macular edema, rubeosis iridis, vitreous hemorrhage and diabetic related-visual injury)) with delayed stomach empty

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Apr 10, 2019

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.

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