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Colonic Glucose vs. Saline Infusion

S

Shandong University

Status

Unknown

Conditions

Gastrointestinal Hormones

Treatments

Dietary Supplement: colonic infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05302206
2021-228

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

15 participants in 2 patient groups

patients with ileostomy without type 2 diabetes
Experimental group
Description:
colonic glucose or saline infusion via ileostomy
Treatment:
Dietary Supplement: colonic infusion
patients with ileostomy with type 2 diabetes
Experimental group
Description:
colonic glucose or saline infusion via ileostomy
Treatment:
Dietary Supplement: colonic infusion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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