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Colonic Glucose vs. Saline Infusion

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05302206
Enrollment
15
Registered
2022-03-31
Start date
2022-04-01
Completion date
2022-08-01
Last updated
2022-03-31

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

Conditions

Gastrointestinal Hormones

Brief summary

The distal ileum and proximal colon, where the glucagon-like peptide 1 (GLP-1) releasing cells predominate, are important organs in mediating glycemic control. The proximal colon 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 proximal colon.

Interventions

DIETARY_SUPPLEMENTcolonic infusion

colonic glucose or colonic saline infusion

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

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
No

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

MeasureTime frameDescription
serum or plasma glucagon changes during colonic infusion180 minutesconcentration of serum or plasma glucagon (pmol/L)
glucose absorption capacity180 minutesestimated glucose absorption rate during colonic glucose infusion
serum or plasma GLP-1 changes during colonic infusion180 minutesconcentration of serum or plasma GLP-1 (pmol/L)
serum or plasma GIP changes during colonic infusion180 minutesconcentration of serum or plasma GIP (pmol/L)
serum or plasma ghrelin changes during colonic infusion180 minutesconcentration of serum or plasma ghrelin (pg/ml)
serum or plasma c-peptide changes during colonic infusion180 minutesconcentration of serum or plasma c-peptide (pmol/L)
serum or plasma insulin changes during colonic infusion180 minutesconcentration of serum or plasma insulin (pmol/L)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026