Skip to main content
OpenTrials
Completed

NCT Number: NCT05030376

Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions

The distal ileum, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, is an important organ in mediating glycemic control. However, the distal ileum is not easy to access and the correspond in vivo research remains to be difficult. The investigators intend to recruit subjects who underwent rectal surgery with simultaneous protective ileostomy and evaluate hormone secretion and glycemic excursions via ileostomy glucose or saline infusion, and quantify the glucose absorption rate within the distal ileum.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Incretins

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University, Jinan, Shandong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and postmenopausal females aged 18 - 75 years
  • Body mass index (BMI) 20 - 35 kg/m2
  • With protective ileostomy due to benign or malignant rectal surgery

Exclusion criteria

  • History of postoperative adjuvant chemotherapy
  • Other significant illness, including epilepsy, cardiovascular or respiratory disease
  • Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (> 2 times upper limit of normal range))
  • Donation of blood within the previous 3 months
  • Participation in any other research studies within the previous 3 months
  • Females who are pre-menopausal
  • Inability to give informed consent
  • Vegetarians

Treatment and study plan

intraileal infusion

Dietary Supplement

intraileal glucose or intraileal saline infusion

Primary outcomes

  1. serum or plasma GLP-1 changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma GLP-1 (pmol/L)

  2. serum or plasma GIP changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma GIP (pmol/L)

  3. serum or plasma ghrelin changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma ghrelin (pg/ml)

  4. serum or plasma c-peptide changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma c-peptide (pmol/L)

  5. serum or plasma insulin changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma insulin (pmol/L)

  6. serum or plasma glucagon changes during intraileal infusion

    Time frame: 180 minutes

    concentration of serum or plasma glucagon (pmol/L)

  7. glucose absorption capacity

    Time frame: 180 minutes

    estimated glucose absorption rate during intraileal glucose infusion

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Shandong First Medical University

Registry information

Official study title

Comparative Effects of Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions in Subjects With Ileostomy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2021
Registry last updated
Apr 26, 2022

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.

Related clinical trials

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