Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.

Study Overview
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Brief Summary
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The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).

Official Title
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Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: speWHE
* Dietary Supplement: WHE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Type 2 diabetes (T2D) diagnosis No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D No daily use of protein drinks Hba1c between 40 mmol/mol and 69 mmol/mol 20 kg/m2 < BMI < 35 kg/m2 Screening blood test: 1200 pmol/l > C-peptid > 370 pmol/l Exclusion Criteria: Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor) Affected screening blood test assessed by the primary investigator(PI)/sponsor Does not understand or speak danish Milk allergy PI finds the patient not fit (e.g. mental illness, too nervous or other)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blinded, randomized, crossover design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WHE (regular whey protein)<br>Regular whey protein. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment. | Dietary Supplement: WHE<br>* 25 gram protein of a regular whey compound<br>|
| Experimental: speWHE (specific whey protein compound)<br>Specific whey protein compound. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment. | Dietary Supplement: speWHE<br>* 25 gram of a specific whey fraction (confidential)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in iAUC for insulin between WHE and speWHE | Difference in iAUC for insulin between WHE and speWHE | OGTT, 3 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in iAUC and concentration differences for GIP |  | OGTT 3 hours | 
| Differences in iAUC and concentration differences for GLP-1 |  | OGTT 3 hours | 
| Differences in iAUC and concentration differences for glucagon |  | OGTT 3 hours | 
| Differences in iAUC and concentration differences for glucose |  | OGTT 3 hours | 
| Differences in iAUC and concentration differences for C-peptid |  | OGTT 3 hours | 
| Differences in iAUC and concentration differences for FFA |  | OGTT 3 hours | 
| Activity measurements |  | 5 days | 
| continuous glucose measurement (CGM) | CGM with time in normal range 4-10 mmol/l, peak after a meal, AUC in the days with the interventions. | 5 days |