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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02477761
• Other study ID #: LisbLungo
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2015
• Last updated: June 22, 2015
• Start date: June 2015
• Est. completion date: September 2015

Study information

• Verified date: June 2015
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: Andrea Natali, Prof
• Phone: +39050992814
• Email: andrea.natali[@]med.unipi.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Dietary Supplement:
• Nutrient preload
Ingestion of a small mixed protein and lipid meal 30 minutes before glucose

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose concentration		330 minutes	No
Secondary	Plasma Insulin concentration		330 minutes	No
Secondary	Plasma C-peptide concentration		330 minutes	No
Secondary	Plasma glucagon-like peptide-1 concentration		330 minutes	No
Secondary	Plasma glucose-dependent insulinotropic polypeptide concentration		330 minutes	No