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

Not Applicable

Completed

• Conditions: Incretins
• Interventions: Dietary Supplement: intraileal infusion

• Registration Number: NCT05030376
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-31
• Study First Posted: 2021-09-01
• Study Start: 2021-09-22
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
patients with ileostomy without type 2 diabetes	intraileal infusion	intraileal glucose or saline infusion via ileostomy
patients with ileostomy with type 2 diabetes	intraileal infusion	intraileal glucose or saline infusion via ileostomy

Primary Outcome Measures

Name	Time	Method
serum or plasma ghrelin changes during intraileal infusion	180 minutes	concentration of serum or plasma ghrelin (pg/ml)
serum or plasma insulin changes during intraileal infusion	180 minutes	concentration of serum or plasma insulin (pmol/L)
serum or plasma GLP-1 changes during intraileal infusion	180 minutes	concentration of serum or plasma GLP-1 (pmol/L)
serum or plasma c-peptide changes during intraileal infusion	180 minutes	concentration of serum or plasma c-peptide (pmol/L)
serum or plasma glucagon changes during intraileal infusion	180 minutes	concentration of serum or plasma glucagon (pmol/L)
serum or plasma GIP changes during intraileal infusion	180 minutes	concentration of serum or plasma GIP (pmol/L)
glucose absorption capacity	180 minutes	estimated glucose absorption rate during intraileal glucose infusion

Trial Locations

Locations (2)

the first affiliated hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China