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

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Effects of Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions in Subjects With Ileostomy

Conditions
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Incretins

Intervention / Treatment
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* Dietary Supplement: intraileal infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with ileostomy without type 2 diabetes<br>intraileal glucose or saline infusion via ileostomy | Dietary Supplement: intraileal infusion<br>* intraileal glucose or intraileal saline infusion<br>|
| Experimental: patients with ileostomy with type 2 diabetes<br>intraileal glucose or saline infusion via ileostomy | Dietary Supplement: intraileal infusion<br>* intraileal glucose or intraileal saline infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum or plasma GLP-1 changes during intraileal infusion | concentration of serum or plasma GLP-1 (pmol/L) | 180 minutes | 
| serum or plasma GIP changes during intraileal infusion | concentration of serum or plasma GIP (pmol/L) | 180 minutes | 
| serum or plasma ghrelin changes during intraileal infusion | concentration of serum or plasma ghrelin (pg/ml) | 180 minutes | 
| serum or plasma c-peptide changes during intraileal infusion | concentration of serum or plasma c-peptide (pmol/L) | 180 minutes | 
| serum or plasma insulin changes during intraileal infusion | concentration of serum or plasma insulin (pmol/L) | 180 minutes | 
| serum or plasma glucagon changes during intraileal infusion | concentration of serum or plasma glucagon (pmol/L) | 180 minutes | 
| glucose absorption capacity | estimated glucose absorption rate during intraileal glucose infusion | 180 minutes |