Clinical trial NCT05030376: Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
Official title: Comparative Effects of Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incretins
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong First Medical University
First posted: 2021-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: serum or plasma GLP-1 changes during intraileal infusion
timeFrame: 180 minutes
measure: serum or plasma GIP changes during intraileal infusion
timeFrame: 180 minutes
measure: serum or plasma ghrelin changes during intraileal infusion
timeFrame: 180 minutes
measure: serum or plasma c-peptide changes during intraileal infusion
timeFrame: 180 minutes
measure: serum or plasma insulin changes during intraileal infusion
timeFrame: 180 minutes
measure: serum or plasma glucagon changes during intraileal infusion
timeFrame: 180 minutes
measure: glucose absorption capacity
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: the first affiliated hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Kexin Wang
role: STUDY_DIRECTOR
References:
citation: Zhang X, Cheng Z, Dong S, Rayner C, Wu T, Zhong M, Zhang G, Wang K, Hu S. Effects of ileal glucose infusion on enteropancreatic hormone secretion in humans: relationship to glucose absorption. Metabolism. 2022 Jun;131:155198. doi: 10.1016/j.metabol.2022.155198. Epub 2022 Apr 6.