MedPath

Effect of a diabetes-specific oral nutritional supplement (ONS) vs. standard ONS on the postprandial glucose response in adults with type 2 diabetes with (risk of) malnutrition.

Recruiting
Conditions
Diabetes Mellitus type 2
Registration Number
NL-OMON24556
Lead Sponsor
Danone Research - Centre for Specialised Nutrition
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

1. Age ≥ 18 yrs;

2. (At risk of) malnourishment, based on the presence of one or more of the following criteria:

Exclusion Criteria

1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis);

2. Any known severe disease, i.e.:

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
4-hour postprandial blood glucose response after consumption of diabetes-specific or standard ONS (iAUC0-4h).
Secondary Outcome Measures
NameTimeMethod
1. 4-hour postprandial responses after consumption of diabetes-specific or standard ONS:<br /><br>A. Blood glucose levels (iAUC0-4h) (serving size);<br /><br>B. Blood insulin levels (iAUC0-4h);<br /><br>C. Blood glucagon levels (iAUC0-4h).<br /><br>2. Postprandial peak blood glucose, insulin and glucagon levels;<br /><br>3. Postprandial delta peak blood glucose, insulin and glucagon levels.
© Copyright 2025. All Rights Reserved by MedPath