NCT04166760

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 14, 2019

Last Update Submit

November 5, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Difference in iAUC for insulin between WHE and speWHE

    Difference in iAUC for insulin between WHE and speWHE

    OGTT, 3 hours.

Secondary Outcomes (8)

  • 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

  • Differences in iAUC and concentration differences for C-peptid

    OGTT 3 hours

  • +3 more secondary outcomes

Study Arms (2)

WHE (regular whey protein)

ACTIVE COMPARATOR

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.

Dietary Supplement: WHE

speWHE (specific whey protein compound)

EXPERIMENTAL

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.

Dietary Supplement: speWHE

Interventions

speWHEDIETARY_SUPPLEMENT

25 gram of a specific whey fraction (confidential)

speWHE (specific whey protein compound)
WHEDIETARY_SUPPLEMENT

25 gram protein of a regular whey compound

WHE (regular whey protein)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • kg/m2 \< BMI \< 35 kg/m2
  • Screening blood test: 1200 pmol/l \> C-peptid \> 370 pmol/l

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Niels Jessen, Professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Double blinded, randomized, crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

January 6, 2020

Primary Completion

June 17, 2020

Study Completion

June 24, 2020

Last Updated

November 6, 2020

Record last verified: 2019-11

Locations

DK(1)