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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Dietary Supplement: WHE; Dietary Supplement: speWHE

• Registration Number: NCT04166760
• Lead Sponsor: University of Aarhus

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-01-06
• Primary Completion: 2020-06-17
• Study Completion: 2020-06-24
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WHE (regular whey protein)	WHE	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.
speWHE (specific whey protein compound)	speWHE	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.

Primary Outcome Measures

Name	Time	Method
Difference in iAUC for insulin between WHE and speWHE	OGTT, 3 hours.	Difference in iAUC for insulin between WHE and speWHE

Secondary Outcome Measures

Name	Time	Method
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	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 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

Trial Locations

Locations (1)

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