Diabetes Mellitus, Type 1NCT02365740
Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options
A study testing gastric emptying test, gut hormones determination and Continuous Glucose Monitoring in people with Diabetes Mellitus, Type 1, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- gastric emptying test, gut hormones determination and Continuous Glucose Monitoring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2014to Nov 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- DM1;
- Use of insulin pump;
- Disease duration ≥ 3 years.
Who cannot join
- Presence of chronic complications of DM (including cardiovascular autonomic neuropathy);
- BMI ≥ 30 kg/m2;
- Presence of chronic diseases other than DM1;
- Diseases that interfere with GE;
- Medications that interfere with blood glucose homeostasis (except insulin) and GE.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dept. of "Medicina Clinica e Chirurgia" of Federico II University
Naples, Naples, 80131
Brunella Capaldo, MD, 0817462311, bcapaldo@unina.it
Roberta Lupoli, MD, 0817462427, sereroby@yahoo.it
About this study
Official title: Postprandial Blood Glucose Control and Gastric Emptying in Patients With Type 1 Diabetes: Pathogenetic Factors, Clinical Relevance and Possible Therapeutic Options
This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms.
In addition, in patients with delayed GE the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.
Read the detailed description
Diabetic patients with a delayed GE will be studied in 2 separate occasions in euglycemic condition and under CGM. On both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g).
On the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load.
On the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. The "tailored" insulin bolus will be defined according to the individual pattern of GE, as follows:
- GE T1/2 121-180 min= 60% as bolus + 40% during following 2 h
- GE T1/2 >180 min= 40% as bolus + 60% during following 4 h Glycemic variability will be assessed by the means of Continuous Glucose Monitoring System and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, M value, mean amplitude of glycemic excursions (MAGE), low blood glucose index (LBGI), high blood glucose index (HBGI).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- gastric emptying test, gut hormones determination, Continuous Glucose Monitoring, Insulin single bolus, Insulin double-wave bolus
- Keywords
- Type 1 Diabetes mellitus, Gastric Emptying, Insulin Infusion Pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric emptying testOther
gastric emptying rate for solid will be determined using the 13C-OBT. Breath samples will be taken before the meal and then at 15-min intervals for a period of 240 min postprandially. The 13C content will be determined by on-line gas chromatographic purification-isotope ratio mass spectrometry (ABCA; Europe Scientific, Crewe, UK). The 13CO2 excretion curves will be analyzed and the half-emptying time (t½) and lag phase (tlag) calculated.
gut hormones determinationOther
blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)
Continuous Glucose MonitoringOther
7 days Continuous Glucose Monitoring
Insulin single bolusDrug
pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load
Insulin double-wave bolusDrug
pre-prandial insulin fractioned into a double-wave bolus
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus Receives: Other: gastric emptying test; Other: gut hormones determination; Other: Continuous Glucose Monitoring; Drug: Insulin single bolus; Drug: Insulin double-wave bolus |
| Controls | Sham comparator | gastric emptying test gut hormones determination Receives: Other: gastric emptying test; Other: gut hormones determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric emptying measure
Measured: 4 hours
Secondary outcomes (4)
gut hormones dosage
Measured: 3 hours
Continuous Glucose Monitoring
Measured: 7 days
postprandial glucose variability after single insulin bolus
Measured: 3 hours
postprandial glucose variability after double-wave insulin bolus
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Federico II 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brunella Capaldo, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365740
- Sponsor's protocol ID
- 248/13
- Status last verified
- Nov 2014
- First submitted
- 4 Feb 2015
- Last updated
- 19 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Blood Glucose Control and Gastric Emptying in Patients With Type 1 Diabetes: Pathogenetic Factors, Clinical Relevance and Possible Therapeutic Options
- ClinicalTrials.gov ID
- NCT02365740
- Acronym / sponsor ID
- 248/13
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Type 1 Diabetes mellitus, Gastric Emptying, Insulin Infusion Pump
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- 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.
This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms.
In addition, in patients with delayed GE the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.
Detailed description
Diabetic patients with a delayed GE will be studied in 2 separate occasions in euglycemic condition and under CGM. On both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g).
On the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load.
On the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. The "tailored" insulin bolus will be defined according to the individual pattern of GE, as follows:
- GE T1/2 121-180 min= 60% as bolus + 40% during following 2 h
- GE T1/2 >180 min= 40% as bolus + 60% during following 4 h Glycemic variability will be assessed by the means of Continuous Glucose Monitoring System and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, M value, mean amplitude of glycemic excursions (MAGE), low blood glucose index (LBGI), high blood glucose index (HBGI).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Other: gastric emptying test, Other: gut hormones determination, Other: Continuous Glucose Monitoring, Drug: Insulin single bolus, Drug: Insulin double-wave bolusgastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus |
| Controls | Sham comparator | Other: gastric emptying test, Other: gut hormones determinationgastric emptying test gut hormones determination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- DM1;
- Use of insulin pump;
- Disease duration ≥ 3 years.
Key exclusion criteria (5 listed)
- Presence of chronic complications of DM (including cardiovascular autonomic neuropathy);
- BMI ≥ 30 kg/m2;
- Presence of chronic diseases other than DM1;
- Diseases that interfere with GE;
- Medications that interfere with blood glucose homeostasis (except insulin) and GE.
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 |
|---|---|---|
| gastric emptying testgastric emptying rate for solid will be determined using the 13C-OBT. Breath samples will be taken before the meal and then at 15-min intervals for a period of 240 min postprandially. The 13C content will be determined by on-line gas chromatographic purification-isotope ratio mass spectrometry (ABCA; Europe Scientific, Crewe, UK). The 13CO2 excretion curves will be analyzed and the half-emptying time (t½) and lag phase (tlag) calculated. | Other | Cases, Controls |
| gut hormones determinationblood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP) | Other | Cases, Controls |
| Continuous Glucose Monitoring7 days Continuous Glucose Monitoring | Other | Cases |
| Insulin single boluspre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load | Drug | Cases |
| Insulin double-wave boluspre-prandial insulin fractioned into a double-wave bolus | Drug | Cases |
Primary outcome
gastric emptying measure
Time frame: 4 hours
4 secondary outcomes
gut hormones dosage
Time frame: 3 hours
Continuous Glucose Monitoring
Time frame: 7 days
postprandial glucose variability after single insulin bolus
Time frame: 3 hours
postprandial glucose variability after double-wave insulin bolus
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2015.
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Dept. of "Medicina Clinica e Chirurgia" of Federico II University
Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric emptying test, gut hormones determination and Continuous Glucose Monitoring in people with Diabetes Mellitus, Type 1, run by Federico II University at 1 site in Italy.
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 5 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 19 Feb 2015. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
gastric emptying measure (time frame: 4 hours). 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 19 Feb 2015.