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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05030376

Enrollment

Registered

2021-09-01

Start date

2021-09-22

Completion date

2022-03-01

Last updated

2022-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incretins

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTintraileal infusion

intraileal glucose or intraileal saline infusion

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026