Effects of 5 or 10 gram of the protein hydrolysate InsuVital* on serum insulin and glucose levels in patients with type 2 diabetes mellitus and the influence of varying carbohydrate loads
- Conditions
- diabetes mellitus type 210018424
- Registration Number
- NL-OMON32298
- Lead Sponsor
- DSM Food Specialties
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 24
• Males or females, 18-70 years old.
• Fasting glucose level > 7 mmol/L after 2 days refraining from medication.
• Are on stable medication with biguanides for at least 3 months.
• Prepared and able to give written informed consent;
• Use of insulin, sulfonylurea derivatives, meglitinides or other antidiabetic drugs except biguanides;
• BMI > 35 kg/m2;
• Females who are pregnant, have the intention to become pregnant within the study period, or who are lactating;
• A present and clinically significant history of ischemic heart disease (such as angina pectoris with an incidence of more than one attack/month), acute myocardial infarction within one year prior to the study or congestive heart failure (defined as NYHA class III or IV);
• Uncontrolled hypertension;
• Active, proliferative retinopathy
• Active or history of liver disease or impaired renal function (defined as a creatinin clearance calculated with the Cockcroft-Gault formula below 60 ml/min);
• Participation in a trial within 3 months prior to the start of the study or more then 4 times a year;
• Loss of 250 ml or more of blood within 3 months prior to screening;
• Any clinical condition, including use of co-medication or laboratory test results that in the opinion of the investigators may jeopardize the health status of the participants.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Serum concentrations and AUC of glucose and insulin.</p><br>
- Secondary Outcome Measures
Name Time Method <p>na</p><br>