Colonic Glucose vs. Saline Infusion

NCT05302206 | Unknown

• 1 other identifier: 2021-228
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Hormones

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

patients with ileostomy without type 2 diabetes

EXPERIMENTAL

colonic glucose or saline infusion via ileostomy

Dietary Supplement: colonic infusion

patients with ileostomy with type 2 diabetes

EXPERIMENTAL

colonic glucose or saline infusion via ileostomy

Dietary Supplement: colonic infusion

Interventions

colonic infusion DIETARY_SUPPLEMENT

colonic glucose or colonic saline infusion

patients with ileostomy with type 2 diabetes; patients with ileostomy without type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

• Kexin Wang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)