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

Qilu Hospital of Shandong University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Incretins

Interventions

intraileal infusionDIETARY_SUPPLEMENT

intraileal glucose or intraileal saline infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Qilu Hospital of Shandong University

Jinan, Shandong, China

the first affiliated hospital of Shandong First Medical University

Jinan, Shandong, China

Outcomes

Primary Outcomes

serum or plasma GLP-1 changes during intraileal infusion

concentration of serum or plasma GLP-1 (pmol/L)

Time frame: 180 minutes

serum or plasma GIP changes during intraileal infusion

concentration of serum or plasma GIP (pmol/L)

Time frame: 180 minutes

serum or plasma ghrelin changes during intraileal infusion

concentration of serum or plasma ghrelin (pg/ml)

Time frame: 180 minutes

serum or plasma c-peptide changes during intraileal infusion

concentration of serum or plasma c-peptide (pmol/L)

Time frame: 180 minutes

serum or plasma insulin changes during intraileal infusion

concentration of serum or plasma insulin (pmol/L)

Time frame: 180 minutes

serum or plasma glucagon changes during intraileal infusion

concentration of serum or plasma glucagon (pmol/L)

Time frame: 180 minutes

glucose absorption capacity

estimated glucose absorption rate during intraileal glucose infusion

Time frame: 180 minutes

Data from ClinicalTrials.gov

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