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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166760
• Other study ID #: TAKE4
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: June 24, 2020

Study information

• Verified date: November 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 24, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• speWHE
25 gram of a specific whey fraction (confidential)
• WHE
25 gram protein of a regular whey compound

Locations

Country	Name	City	State
Denmark	Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in iAUC for insulin between WHE and speWHE	Difference in iAUC for insulin between WHE and speWHE	OGTT, 3 hours.
Secondary	Differences in iAUC and concentration differences for GIP		OGTT 3 hours
Secondary	Differences in iAUC and concentration differences for GLP-1		OGTT 3 hours
Secondary	Differences in iAUC and concentration differences for glucagon		OGTT 3 hours
Secondary	Differences in iAUC and concentration differences for glucose		OGTT 3 hours
Secondary	Differences in iAUC and concentration differences for C-peptid		OGTT 3 hours
Secondary	Differences in iAUC and concentration differences for FFA		OGTT 3 hours
Secondary	Activity measurements		5 days
Secondary	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