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

Incretins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05030376
• Other study ID #: QLYY-CRC-2020-001
• Status: Completed
• Phase: N/A
• Start date: September 22, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Incretins

Intervention

Dietary Supplement:
• intraileal infusion
intraileal glucose or intraileal saline infusion

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	the first affiliated hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	The First Affiliated Hospital of Shandong First Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum or plasma GLP-1 changes during intraileal infusion	concentration of serum or plasma GLP-1 (pmol/L)	180 minutes
Primary	serum or plasma GIP changes during intraileal infusion	concentration of serum or plasma GIP (pmol/L)	180 minutes
Primary	serum or plasma ghrelin changes during intraileal infusion	concentration of serum or plasma ghrelin (pg/ml)	180 minutes
Primary	serum or plasma c-peptide changes during intraileal infusion	concentration of serum or plasma c-peptide (pmol/L)	180 minutes
Primary	serum or plasma insulin changes during intraileal infusion	concentration of serum or plasma insulin (pmol/L)	180 minutes
Primary	serum or plasma glucagon changes during intraileal infusion	concentration of serum or plasma glucagon (pmol/L)	180 minutes
Primary	glucose absorption capacity	estimated glucose absorption rate during intraileal glucose infusion	180 minutes