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

University of Aarhus16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

speWHEDIETARY_SUPPLEMENT

25 gram of a specific whey fraction (confidential)

WHEDIETARY_SUPPLEMENT

25 gram protein of a regular whey compound

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Difference in iAUC for insulin between WHE and speWHE

Time frame: OGTT, 3 hours.

Secondary Outcomes

Differences in iAUC and concentration differences for GIP

Time frame: OGTT 3 hours

Differences in iAUC and concentration differences for GLP-1

Time frame: OGTT 3 hours

Differences in iAUC and concentration differences for glucagon

Time frame: OGTT 3 hours

Differences in iAUC and concentration differences for glucose

Time frame: OGTT 3 hours

Differences in iAUC and concentration differences for C-peptid

Time frame: OGTT 3 hours

Differences in iAUC and concentration differences for FFA

Time frame: OGTT 3 hours

Activity measurements

Time frame: 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.

Time frame: 5 days

Data from ClinicalTrials.gov

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