Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes

June 22, 2015 updated by: Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. The effect on 5 h glucose excursions of a combination of protein and fat given before carbohydrate is still unknown.

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56127
        • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • Subjects taking anoretic drugs
  • Subjects on steroid treatment
  • Subjects after bariatric surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Water preload
During the "Water preload" study, each subject consume 500 ml of water 30 minutes before a 75 g glucose ingestion
Experimental: Nutrient preload
During the "Nutrient preload" study, each subject consume a small mixed meal 30 minutes before a 75 g glucose ingestion. 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: Nutrient preload
Ingestion of a small mixed protein and lipid meal 30 minutes before glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma glucose concentration
Time Frame: 330 minutes
330 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Insulin concentration
Time Frame: 330 minutes
330 minutes
Plasma C-peptide concentration
Time Frame: 330 minutes
330 minutes
Plasma glucagon-like peptide-1 concentration
Time Frame: 330 minutes
330 minutes
Plasma glucose-dependent insulinotropic polypeptide concentration
Time Frame: 330 minutes
330 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Study Chair: Andrea Natali, Prof, Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LisbLungo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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