Colonic Glucose vs. Saline Infusion

Not Applicable

• Conditions: Gastrointestinal Hormones
• Interventions: Dietary Supplement: colonic infusion

• Registration Number: NCT05302206
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The distal ileum and proximal colon, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, are important organs in mediating glycemic control. The proximal colon 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 proximal colon.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Study Start: 2022-04-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

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