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

Not Applicable

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: gastric emptying test; Other: gut hormones determination; Other: Continuous Glucose Monitoring; Drug: Insulin single bolus; Drug: Insulin double-wave bolus

• Registration Number: NCT02365740
• Lead Sponsor: Federico II University

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).

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-18
• Last Update Submitted: 2015-02-18
• Study First Posted: 2015-02-19
• Last Update Posted: 2015-02-19
• Primary Completion: 2015-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cases	gastric emptying test	gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
Cases	Insulin double-wave bolus	gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
Controls	gastric emptying test	gastric emptying test gut hormones determination
Controls	gut hormones determination	gastric emptying test gut hormones determination
Cases	gut hormones determination	gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
Cases	Continuous Glucose Monitoring	gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
Cases	Insulin single bolus	gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus

Primary Outcome Measures

Name	Time	Method
gastric emptying measure	4 hours

Secondary Outcome Measures

Name	Time	Method
Continuous Glucose Monitoring	7 days
postprandial glucose variability after single insulin bolus	3 hours
postprandial glucose variability after double-wave insulin bolus	3 hours
gut hormones dosage	3 hours

Trial Locations

Locations (1)

Dept. of "Medicina Clinica e Chirurgia" of Federico II University; 🇮🇹 Naples, Italy