Postprandial Blood Glucose Control and Gastric Emptying in Type 1 Diabetes: Pathogenetic Factors and Therapeutic Options

NCT ID: NCT02365740

Last Updated: 2015-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

Brief 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. 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).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cases

gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus

Group Type: EXPERIMENTAL

gastric emptying test

Intervention Type: OTHER

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 determination

Intervention Type: OTHER

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 Monitoring

Intervention Type: OTHER

7 days Continuous Glucose Monitoring

Insulin single bolus

Intervention Type: DRUG

pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load

Insulin double-wave bolus

Intervention Type: DRUG

pre-prandial insulin fractioned into a double-wave bolus

Controls

gastric emptying test gut hormones determination

Group Type: SHAM_COMPARATOR

gastric emptying test

Intervention Type: OTHER

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 determination

Intervention Type: OTHER

blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)

Interventions

gastric emptying test

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.

Intervention Type: OTHER

gut hormones determination

blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)

Intervention Type: OTHER

Continuous Glucose Monitoring

7 days Continuous Glucose Monitoring

Intervention Type: OTHER

Insulin single bolus

pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load

Intervention Type: DRUG

Insulin double-wave bolus

pre-prandial insulin fractioned into a double-wave bolus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• DM1;
• Use of insulin pump;
• Disease duration ≥ 3 years.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Brunella Capaldo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept. of "Medicina Clinica e Chirurgia" of Federico II University

Naples, Naples, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Brunella Capaldo, MD

Role: primary

bcapaldo@unina.it

0817462311

Roberta Lupoli, MD

Role: backup

sereroby@yahoo.it

0817462427

Other Identifiers

248/13

Identifier Type: -

Identifier Source: org_study_id