Colonic Glucose vs. Saline Infusion

Gastrointestinal Hormones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05302206
• Other study ID #: 2021-228
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 1, 2022

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• 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

• Gastrointestinal Hormones

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

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