Oral Prolonged-release Supplements Impact on Glycaemic Index, Satiety ranking in patients with Type 2 Diabetes and Role on Renal Function: A Randomized Cross-Over Trial

UMIN ID: UMIN000055595

Registered date:24/09/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Diabetes Mellitus, Impaired Kidney Function
• Date of first enrollment: 2024/01/15
• Target sample size: 29
• Countries of recruitment: South America
• Study type: Interventional

Intervention(s)

Dietary Supplement: Ensure Abbott Nutrition
Dietary Supplement: Nepro Abbott Nutrition
Dietary Supplement: Glucerna SR Abbott Nutrition
Dietary Supplement: Enterex Renal Victus USA
Dietary Supplement: Glycolab

Outcome(s)

• Primary Outcome: Postprandial blood glucose and insulin, glycemic index, glycemic load, and satiety variables comparing oral nutritional supplements specific for renal patients with a standard supplement and with a supplement specific for diabetics
• Secondary Outcome: Include all biochemical and anthropometric characteristics of the subjects.

Key inclusion & exclusion criteria

• Age minimum: 57years-old
• Age maximum: 62years-old
• Gender: Male and Female
• Exclude criteria: Type 1 Diabetes Diabetic ketoacidosis Congestive heart failure Gastric, renal or hepatic diseases Myocardial infarction Stroke Subjects with insulin therapy, antibiotic therapy or corticosteroids End-stage organ failure Individuals with organ transplantation Coagulation or bleeding disorder Infectious or chronic contagious disease (such as tuberculosis, hepatitis B or C or HIV).

Related Information

• Primary Sponsor: Universidad Andres Bello
• Source(s) of Monetary Support: Universidad Andres Bello