Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Difference in iAUC for insulin between WHE and speWHE
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
WHE (regular whey protein)
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.
Intervention: WHE (Dietary Supplement)
speWHE (specific whey protein compound)
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.
Intervention: speWHE (Dietary Supplement)
Outcomes
Primary Outcomes
Difference in iAUC for insulin between WHE and speWHE
Time Frame: OGTT, 3 hours.
Difference in iAUC for insulin between WHE and speWHE
Secondary Outcomes
- 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)(5 days)
- 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)