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

S

Shandong University

Status

Completed

Conditions

Incretins

Treatments

Dietary Supplement: intraileal infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05030376
QLYY-CRC-2020-001

Details and patient eligibility

About

The distal ileum, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, is an important organ in mediating glycemic control. However, the distal ileum 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 distal ileum.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts 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:
intraileal glucose or saline infusion via ileostomy
Treatment:
Dietary Supplement: intraileal infusion
patients with ileostomy with type 2 diabetes
Experimental group
Description:
intraileal glucose or saline infusion via ileostomy
Treatment:
Dietary Supplement: intraileal infusion

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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