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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2022-03-01

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.

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Detailed Description

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Conditions

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Incretins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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patients with ileostomy without type 2 diabetes

intraileal glucose or saline infusion via ileostomy

Group Type EXPERIMENTAL

intraileal infusion

Intervention Type DIETARY_SUPPLEMENT

intraileal glucose or intraileal saline infusion

patients with ileostomy with type 2 diabetes

intraileal glucose or saline infusion via ileostomy

Group Type EXPERIMENTAL

intraileal infusion

Intervention Type DIETARY_SUPPLEMENT

intraileal glucose or intraileal saline infusion

Interventions

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intraileal infusion

intraileal glucose or intraileal saline infusion

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes