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OpenTrials
Completed

NCT Number: NCT02342834

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, 56127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Small mixed protein and lipid meal

Dietary Supplement

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

Primary outcomes

  1. Plasma glucose response during the Oral Glucose Tolerance Test

    Time frame: 120 minutes

Secondary outcomes

  1. Insulin secretion, estimated from C-peptide deconvolution

    Time frame: 120 minutes

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

    Time frame: 120 minutes

    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.

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

    Time frame: 120 minutes

  4. 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

    Time frame: 120 minutes

  5. Incretin secretion (plasma GLP-1, plasma GIP)

    Time frame: 120 minutes

  6. Plasma glucagon

    Time frame: 120 minutes

  7. Plasma Non Esterified Fatty Acids

    Time frame: 120 minutes

  8. Beta cells function parameters (glucose sensitivity, rate sensitivity, potentiation factor ratio), calculated by modeling insulin secretion and glucose concentration.

    Time frame: 120 minutes

  9. Endothelial function assessed as the reactive hyperemia index by an EndoPAT device

    Time frame: fasting, 60 min and 120 min during the control and preload OGTT

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero, Universitaria Pisana

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jan 21, 2015
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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