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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
speWHE
WHE
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

WHE (regular whey protein)

speWHE (specific whey protein compound)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Difference in iAUC for insulin between WHE and speWHE
Difference in iAUC for insulin between WHE and speWHE

Secondary Outcome Measures

Differences in iAUC and concentration differences for GIP
Differences in iAUC and concentration differences for GLP-1
Differences in iAUC and concentration differences for glucagon
Differences in iAUC and concentration differences for glucose
Differences in iAUC and concentration differences for C-peptid
Differences in iAUC and concentration differences for FFA
Activity measurements
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.

Full Information

First Posted
November 14, 2019
Last Updated
November 5, 2020
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT04166760
Brief Title
Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
Official Title
Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
June 17, 2020 (Actual)
Study Completion Date
June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double blinded, randomized, crossover design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WHE (regular whey protein)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
speWHE (specific whey protein compound)
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
speWHE
Intervention Description
25 gram of a specific whey fraction (confidential)
Intervention Type
Dietary Supplement
Intervention Name(s)
WHE
Intervention Description
25 gram protein of a regular whey compound
Primary Outcome Measure Information:
Title
Difference in iAUC for insulin between WHE and speWHE
Description
Difference in iAUC for insulin between WHE and speWHE
Time Frame
OGTT, 3 hours.
Secondary Outcome Measure Information:
Title
Differences in iAUC and concentration differences for GIP
Time Frame
OGTT 3 hours
Title
Differences in iAUC and concentration differences for GLP-1
Time Frame
OGTT 3 hours
Title
Differences in iAUC and concentration differences for glucagon
Time Frame
OGTT 3 hours
Title
Differences in iAUC and concentration differences for glucose
Time Frame
OGTT 3 hours
Title
Differences in iAUC and concentration differences for C-peptid
Time Frame
OGTT 3 hours
Title
Differences in iAUC and concentration differences for FFA
Time Frame
OGTT 3 hours
Title
Activity measurements
Time Frame
5 days
Title
continuous glucose measurement (CGM)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Jessen, Professor
Organizational Affiliation
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Official's Role
Study Director
Facility Information:
Facility Name
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
City
Aarhus
Country
Denmark

12. IPD Sharing Statement

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

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