Effects of a Small Protein and Lipid Preload on Glucose Tolerance in Subjects With Impaired Glucose Homeostasis

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Mechanisms Through Which a Small Protein and Lipid Preload Improves Glucose Tolerance in Subjects With Impaired Glucose Homeostasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342834
• Other study ID #: LISBONA
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is:

• to measure the size of the effect on glucose tolerance of a small mixed protein and lipid meal given as a pre-load in individuals with different glucose tolerance status

• to investigate the underlying mechanisms by accurately evaluating beta cell function, insulin sensitivity, insulin clearance and glucose kinetics (oral absorption, endogenous production, rate of utilization) together with gut hormones plasma concentration.

Description:

As supported by experimental and clinical data, oral carbohydrate tolerance is influenced by the coingestion of nutrients through multiple mechanisms. The ingestion itself, the contact with the gastric mucosa, the arrival into the intestine and the subsequent digestion are known to produce neural reflexes, hormonal responses and plasma substrates gradients which, by modulating gastric emptying, insulin secretion and insulin clearance participate in the regulation of postprandial glycaemia. The size of this effect is influenced by a number of factors: the specific nutrient chemical characteristics (fat vs protein and composition) and their physical properties (solid vs liquid), the timing (pre-load vs coingestion) and finally the individual glucose tolerance status. To our knowledge, the effect on glucose excursions of a combination of protein and fat given before carbohydrate is still unknown and also unknown is the contribution of different mechanisms involved in the control of glucose homeostasis in subjects with different degrees of glucose tolerance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy, prediabetic or diet-controlled type 2 diabetic patients

• Subjects = 18 and =65 years of age

• Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)

• Normal liver and kidney function

• Normal thyroid function

• Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

• Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.

• Type 1 or insulin treated diabetes.

• Pregnancy or lactation

• Illicit drug abuse or alcoholism

• Subject treated with insulin or treatment

• Subjects taking anoretic drugs

• Subjects on steroid treatment

• Subjects after bariatric surgery.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• Small mixed protein and lipid meal
Ingestion of a small mixed protein and lipid meal 30 minutes before glucose

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose response during the Oral Glucose Tolerance Test		120 minutes
Secondary	Insulin secretion, estimated from C-peptide deconvolution		120 minutes
Secondary	Insulin sensitivity, estimated from glucose and insulin levels during the Oral Glucose Tolerance Test with the use of Oral Glucose Insulin Sensitivity index	The Oral Glucose Insulin Sensitivity index (OGIS; equation for a 2-h oral glucose test with a glucose dose of 75 g) is the mean glucose clearance change (basal vs OGTT 60-120 min), divided by the mean plasma insulin concentration gradient over the same time interval.	120 minutes
Secondary	Insulin clearance, estimated by calculating the Insulin secretion/Plasma insulin ratio		120 minutes
Secondary	Glucose fluxes (intestinal glucose absorption, endogenous glucose production, rate of disappearance of plasma glucose), assessed by modeling glucose tracers enrichments using a standard double tracers technique		120 minutes
Secondary	Incretin secretion (plasma GLP-1, plasma GIP)		120 minutes
Secondary	Plasma glucagon		120 minutes
Secondary	Plasma Non Esterified Fatty Acids		120 minutes
Secondary	Beta cells function parameters (glucose sensitivity, rate sensitivity, potentiation factor ratio), calculated by modeling insulin secretion and glucose concentration.		120 minutes
Secondary	Endothelial function assessed as the reactive hyperemia index by an EndoPAT device		fasting, 60 min and 120 min during the control and preload OGTT