Diabetes Mellitus, Type 2
Conditions
Brief summary
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).
Interventions
DIETARY_SUPPLEMENTspeWHE
25 gram of a specific whey fraction (confidential)
DIETARY_SUPPLEMENTWHE
25 gram protein of a regular whey compound
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blinded, randomized, crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in iAUC for insulin between WHE and speWHE | OGTT, 3 hours. | Difference in iAUC for insulin between WHE and speWHE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 GIP | OGTT 3 hours | — |
| Differences in iAUC and concentration differences for FFA | OGTT 3 hours | — |
| Activity measurements | 5 days | — |
| continuous glucose measurement (CGM) | 5 days | CGM with time in normal range 4-10 mmol/l, peak after a meal, AUC in the days with the interventions. |
| Differences in iAUC and concentration differences for C-peptid | OGTT 3 hours | — |
Countries
Denmark
Outcome results
None listed