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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02477761
Enrollment
7
Registered
2015-06-23
Start date
2015-06-30
Completion date
2015-09-30
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTNutrient preload

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

Sponsors

Azienda Ospedaliero, Universitaria Pisana
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Plasma glucose concentration330 minutes

Secondary

MeasureTime frame
Plasma Insulin concentration330 minutes
Plasma C-peptide concentration330 minutes
Plasma glucagon-like peptide-1 concentration330 minutes
Plasma glucose-dependent insulinotropic polypeptide concentration330 minutes

Countries

Italy

Contacts

Primary ContactAndrea Natali, Prof
andrea.natali@med.unipi.it+39050992814

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026