- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030376
Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
April 25, 2022 updated by: Sanyuan Hu, Qilu Hospital of Shandong University
Comparative Effects of Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions in Subjects With Ileostomy
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Qilu Hospital Of Shandong University
-
Jinan, Shandong, China, 250012
- The First Affiliated Hospital Of Shandong First Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients with ileostomy without type 2 diabetes
intraileal glucose or saline infusion via ileostomy
|
intraileal glucose or intraileal saline infusion
|
Experimental: patients with ileostomy with type 2 diabetes
intraileal glucose or saline infusion via ileostomy
|
intraileal glucose or intraileal saline infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum or plasma GLP-1 changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma GLP-1 (pmol/L)
|
180 minutes
|
serum or plasma GIP changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma GIP (pmol/L)
|
180 minutes
|
serum or plasma ghrelin changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma ghrelin (pg/ml)
|
180 minutes
|
serum or plasma c-peptide changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma c-peptide (pmol/L)
|
180 minutes
|
serum or plasma insulin changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma insulin (pmol/L)
|
180 minutes
|
serum or plasma glucagon changes during intraileal infusion
Time Frame: 180 minutes
|
concentration of serum or plasma glucagon (pmol/L)
|
180 minutes
|
glucose absorption capacity
Time Frame: 180 minutes
|
estimated glucose absorption rate during intraileal glucose infusion
|
180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Kexin Wang, Qilu Hospital Of Shandong University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2021
Primary Completion (Actual)
March 1, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 31, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
April 26, 2022
Last Update Submitted That Met QC Criteria
April 25, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- QLYY-CRC-2020-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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