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

Azienda Ospedaliero, Universitaria Pisana

Status: Unknown

Conditions: Diabetes

Treatments: Dietary Supplement: Nutrient preload

Study type: Interventional

Funder types: Other

Identifiers

NCT02477761

LisbLungo

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Water preload

No Intervention group

Description:

During the "Water preload" study, each subject consume 500 ml of water 30 minutes before a 75 g glucose ingestion

Nutrient preload

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Nutrient preload