Metabolic Effects of the Manipulation of Nutrient Sequence in the Main Meals in Type 2 Diabetic Patients

Azienda Ospedaliero, Universitaria Pisana

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Behavioral: Modified Diet; Behavioral: Standard Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02442024

CEPPO

Details and patient eligibility

About

The investigators aimed at evaluating the metabolic effects of the inversion of the typical Italian sequence of food ingestion at the main meals in type 2 diabetic patients.

Full description

An intervention group follows a modified diet over a period of two months in which the ingestion of protein and lipid happens before that of carbohydrates. A control group follows a standardized diet in which the ingestion of carbohydrates happens before that of protein and lipid. Both diets contain a reduced intake of high-glycemic index meals, saturated fatty acids, trans fatty acids and alcohol.

On four days separated by one month each other (two before the beginning of the diet and two after 1 month and 2 months of diet) we measure clinical and metabolic parameters (weight, waist and hip circumferences, glucose, glycated hemoglobin, fructosamine, lipid profile) to compare the effects of the two diets.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Well-controlled type 2 diabetes
• HbA1c 48-58 mmol/mol (6.5-7.5%)
• Treatment with metformin or diet only
• BMI: < 35 kg/m^2

Exclusion criteria

• Autoimmune diseases, neoplasia, heart, kidney, liver or respiratory failure
• Pregnancy
• Bariatric surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Modified diet

Experimental group

Description:

This group will follow a modified diet over a period of two months.

Treatment:

Behavioral: Modified Diet

Standard diet

Active Comparator group

Description:

This group will follow a standardized diet over a period of two months.

Treatment:

Behavioral: Standard Diet