Gastrointestinal HormonesNCT05302206
Colonic Glucose vs. Saline Infusion
A study testing colonic infusion in people with Gastrointestinal Hormones, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Hormones
- What is being tested?
- colonic infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Aug 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
- No healthy volunteers
- 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
1 site in 1 country.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Xiang Zhang, +8618560089182, xiang.zhang02@hotmail.com
Zhiqiang Cheng, hill988276@sina.com
About this study
Official title: Colonic Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
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.
- Conditions
- Gastrointestinal Hormones
- Being tested
- colonic infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonic infusionDietary supplement
colonic glucose or colonic saline infusion
| Study group | Role | What they receive |
|---|---|---|
| patients with ileostomy without type 2 diabetes | Experimental | colonic glucose or saline infusion via ileostomy Receives: Dietary Supplement: colonic infusion |
| patients with ileostomy with type 2 diabetes | Experimental | colonic glucose or saline infusion via ileostomy Receives: Dietary Supplement: colonic 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 colonic infusion
concentration of serum or plasma GLP-1 (pmol/L)
Measured: 180 minutes
serum or plasma GIP changes during colonic infusion
concentration of serum or plasma GIP (pmol/L)
Measured: 180 minutes
serum or plasma ghrelin changes during colonic infusion
concentration of serum or plasma ghrelin (pg/ml)
Measured: 180 minutes
serum or plasma c-peptide changes during colonic infusion
concentration of serum or plasma c-peptide (pmol/L)
Measured: 180 minutes
serum or plasma insulin changes during colonic infusion
concentration of serum or plasma insulin (pmol/L)
Measured: 180 minutes
serum or plasma glucagon changes during colonic infusion
concentration of serum or plasma glucagon (pmol/L)
Measured: 180 minutes
glucose absorption capacity
estimated glucose absorption rate during colonic 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 posted31 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HormonesStudies of the same condition, open and under way.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- 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
- NCT05302206
- Sponsor's protocol ID
- 2021-228
- Status last verified
- Mar 2022
- First submitted
- 21 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonic Glucose vs. Saline Infusion on Hormone Secretion and Glycemic Excursions
- ClinicalTrials.gov ID
- NCT05302206
- Acronym / sponsor ID
- 2021-228
- Conditions
- Gastrointestinal Hormones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 31 Mar 2022 (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 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.
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: colonic infusioncolonic glucose or saline infusion via ileostomy |
| patients with ileostomy with type 2 diabetes | Experimental | Dietary Supplement: colonic infusioncolonic glucose or saline infusion via ileostomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| colonic infusioncolonic glucose or colonic 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 colonic infusion
Time frame: 180 minutes
concentration of serum or plasma GLP-1 (pmol/L)
serum or plasma GIP changes during colonic infusion
Time frame: 180 minutes
concentration of serum or plasma GIP (pmol/L)
serum or plasma ghrelin changes during colonic infusion
Time frame: 180 minutes
concentration of serum or plasma ghrelin (pg/ml)
serum or plasma c-peptide changes during colonic infusion
Time frame: 180 minutes
concentration of serum or plasma c-peptide (pmol/L)
serum or plasma insulin changes during colonic infusion
Time frame: 180 minutes
concentration of serum or plasma insulin (pmol/L)
serum or plasma glucagon changes during colonic 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 colonic glucose infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colonic infusion in people with Gastrointestinal Hormones, run by Qilu Hospital of Shandong University at 1 site 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: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum or plasma GLP-1 changes during colonic 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?
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 31 Mar 2022.