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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Postprandial Blood Glucose Control and Gastric Emptying in Patients With Type 1 Diabetes: Pathogenetic Factors, Clinical Relevance and Possible Therapeutic Options

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02365740
• Other study ID #: 248/13
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: February 18, 2015
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2014
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Other:
• 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.
• 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)
• Continuous Glucose Monitoring
7 days Continuous Glucose Monitoring

Drug:
• Insulin single bolus
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
pre-prandial insulin fractioned into a double-wave bolus

Locations

Country	Name	City	State
Italy	Dept. of "Medicina Clinica e Chirurgia" of Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric emptying measure		4 hours	No
Secondary	gut hormones dosage		3 hours	No
Secondary	Continuous Glucose Monitoring		7 days	No
Secondary	postprandial glucose variability after single insulin bolus		3 hours	No
Secondary	postprandial glucose variability after double-wave insulin bolus		3 hours	No