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

NCT ID: NCT02342834

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-03-31

Brief 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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control

During the "control" study, each subject ingest 500 ml of water 30 minutes before a standard 75 g Oral Glucose Tolerance Test

Group Type: NO_INTERVENTION

No interventions assigned to this group

Small mixed protein and lipid meal

During the "preload" study, each subject ingest a small mixed meal 30 minutes before a standard 75 g Oral Glucose Tolerance Test. The meal is composed by 50 g of parmesan cheese, one small size boiled egg and 300 ml of water (250 kcal, 23 g protein, 17 g fat and 2 g of carbohydrate).

Group Type: EXPERIMENTAL

Small mixed protein and lipid meal

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of a small mixed protein and lipid meal 30 minutes before glucose

Interventions

Small mixed protein and lipid meal

Ingestion of a small mixed protein and lipid meal 30 minutes before glucose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: lead

Responsible Party

Andrea Natali

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Natali, Professor

Role: STUDY_CHAIR

Azienda Ospedaliero, Universitaria Pisana

Locations

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Countries

Italy

References

Trico D, Frascerra S, Baldi S, Mengozzi A, Nesti L, Mari A, Natali A. The insulinotropic effect of a high-protein nutrient preload is mediated by the increase of plasma amino acids in type 2 diabetes. Eur J Nutr. 2019 Sep;58(6):2253-2261. doi: 10.1007/s00394-018-1778-y. Epub 2018 Jul 14.

Reference Type: DERIVED

PMID: 30008106 (View on PubMed)

Trico D, Baldi S, Tulipani A, Frascerra S, Macedo MP, Mari A, Ferrannini E, Natali A. Mechanisms through which a small protein and lipid preload improves glucose tolerance. Diabetologia. 2015 Nov;58(11):2503-12. doi: 10.1007/s00125-015-3710-9. Epub 2015 Jul 30.

Reference Type: DERIVED

PMID: 26224101 (View on PubMed)

Other Identifiers

LISBONA

Identifier Type: -

Identifier Source: org_study_id