Colonic Glucose vs. Saline Infusion

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Hormones
• Intervention / Treatment: Dietary supplement: colonic infusion

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Xiang Zhang; Phone Number: +8618560089182; Email: xiang.zhang02@hotmail.com
      • Contact: Zhiqiang Cheng; Email: hill988276@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with ileostomy without type 2 diabetes; colonic glucose or saline infusion via ileostomy	Dietary supplement: colonic infusion; colonic glucose or colonic saline infusion
Experimental: patients with ileostomy with type 2 diabetes; colonic glucose or saline infusion via ileostomy	Dietary supplement: colonic infusion; colonic glucose or colonic saline infusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Director: Kexin Wang, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021-228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No