NCT02342834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

5.2 years

First QC Date

January 13, 2015

Last Update Submit

March 18, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Plasma glucose response during the Oral Glucose Tolerance Test

    120 minutes

Secondary Outcomes (9)

  • Insulin secretion, estimated from C-peptide deconvolution

    120 minutes

  • Insulin sensitivity, estimated from glucose and insulin levels during the Oral Glucose Tolerance Test with the use of Oral Glucose Insulin Sensitivity index

    120 minutes

  • Insulin clearance, estimated by calculating the Insulin secretion/Plasma insulin ratio

    120 minutes

  • 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

  • Incretin secretion (plasma GLP-1, plasma GIP)

    120 minutes

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Small mixed protein and lipid meal

EXPERIMENTAL

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).

Dietary Supplement: Small mixed protein and lipid meal

Interventions

Small mixed protein and lipid mealDIETARY_SUPPLEMENT

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

Small mixed protein and lipid meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

Location

Related Publications (2)

  • 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.

    PMID: 30008106DERIVED

  • 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.

    PMID: 26224101DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrea Natali, Professor

    Azienda Ospedaliero, Universitaria Pisana

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 21, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

IT(1)