IncretinsNCT05030376
Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
A study testing intraileal infusion in people with Incretins, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Incretins
- What is being tested?
- intraileal infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 22 Sep 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
the first affiliated hospital of Shandong First Medical University
Jinan, Shandong, 250012
About this study
Official title: 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.
- Conditions
- Incretins
- Being tested
- intraileal infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraileal infusionDietary supplement
intraileal glucose or intraileal saline infusion
| Study group | Role | What they receive |
|---|---|---|
| patients with ileostomy without type 2 diabetes | Experimental | intraileal glucose or saline infusion via ileostomy Receives: Dietary Supplement: intraileal infusion |
| patients with ileostomy with type 2 diabetes | Experimental | intraileal glucose or saline infusion via ileostomy Receives: Dietary Supplement: intraileal infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum or plasma GLP-1 changes during intraileal infusion
concentration of serum or plasma GLP-1 (pmol/L)
Measured: 180 minutes
serum or plasma GIP changes during intraileal infusion
concentration of serum or plasma GIP (pmol/L)
Measured: 180 minutes
serum or plasma ghrelin changes during intraileal infusion
concentration of serum or plasma ghrelin (pg/ml)
Measured: 180 minutes
serum or plasma c-peptide changes during intraileal infusion
concentration of serum or plasma c-peptide (pmol/L)
Measured: 180 minutes
serum or plasma insulin changes during intraileal infusion
concentration of serum or plasma insulin (pmol/L)
Measured: 180 minutes
serum or plasma glucagon changes during intraileal infusion
concentration of serum or plasma glucagon (pmol/L)
Measured: 180 minutes
glucose absorption capacity
estimated glucose absorption rate during intraileal glucose infusion
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start22 Sep 2021
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IncretinsStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong First Medical University
- Responsible party
- Principal investigator, Sanyuan Hu, Qilu Hospital of Shandong University
- Investigators
- Kexin Wang, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030376
- Sponsor's protocol ID
- QLYY-CRC-2020-001
- Status last verified
- Apr 2022
- First submitted
- 23 Aug 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang X, Cheng Z, Dong S, Rayner C, Wu T, Zhong M, Zhang G, Wang K, Hu S. Effects of ileal glucose infusion on enteropancreatic hormone secretion in humans: relationship to glucose absorption. Metabolism. 2022 Jun;131:155198. doi: 10.1016/j.metabol.2022.155198. Epub 2022 Apr 6.
PubMed 35395220
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Intraileal Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT05030376
- Acronym / sponsor ID
- QLYY-CRC-2020-001
- Conditions
- Incretins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong First Medical University
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with ileostomy without type 2 diabetes | Experimental | Dietary Supplement: intraileal infusionintraileal glucose or saline infusion via ileostomy |
| patients with ileostomy with type 2 diabetes | Experimental | Dietary Supplement: intraileal infusionintraileal glucose or saline infusion via ileostomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraileal infusionintraileal glucose or intraileal saline infusion | Dietary supplement | patients with ileostomy with type 2 diabetes, patients with ileostomy without type 2 diabetes |
Primary outcome
serum or plasma GLP-1 changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma GLP-1 (pmol/L)
serum or plasma GIP changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma GIP (pmol/L)
serum or plasma ghrelin changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma ghrelin (pg/ml)
serum or plasma c-peptide changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma c-peptide (pmol/L)
serum or plasma insulin changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma insulin (pmol/L)
serum or plasma glucagon changes during intraileal infusion
Time frame: 180 minutes
concentration of serum or plasma glucagon (pmol/L)
glucose absorption capacity
Time frame: 180 minutes
estimated glucose absorption rate during intraileal glucose infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Derived from this study: PubMed 35395220Zhang X, Cheng Z, Dong S, Rayner C, Wu T, Zhong M, Zhang G, Wang K, Hu S. Effects of ileal glucose infusion on enteropancreatic hormone secretion in humans: relationship to glucose absorption. Metabolism. 2022 Jun;131:155198. doi: 10.1016/j.metabol.2022.155198. Epub 2022 Apr 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kexin Wang study director
Qilu Hospital of Shandong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraileal infusion in people with Incretins, run by Qilu Hospital of Shandong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum or plasma GLP-1 changes during intraileal infusion (time frame: 180 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05030376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.