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Completed

NCT Number: NCT04166760

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

speWHE

Dietary Supplement

25 gram of a specific whey fraction (confidential)

WHE

Dietary Supplement

25 gram protein of a regular whey compound

Primary outcomes

  1. 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

  1. Differences in iAUC and concentration differences for GIP

    Time frame: OGTT 3 hours

  2. Differences in iAUC and concentration differences for GLP-1

    Time frame: OGTT 3 hours

  3. Differences in iAUC and concentration differences for glucagon

    Time frame: OGTT 3 hours

  4. Differences in iAUC and concentration differences for glucose

    Time frame: OGTT 3 hours

  5. Differences in iAUC and concentration differences for C-peptid

    Time frame: OGTT 3 hours

  6. Differences in iAUC and concentration differences for FFA

    Time frame: OGTT 3 hours

  7. Activity measurements

    Time frame: 5 days

  8. continuous glucose measurement (CGM)

    Time frame: 5 days

    CGM with time in normal range 4-10 mmol/l, peak after a meal, AUC in the days with the interventions.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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