Diabetes Mellitus, Type 2NCT04166760
Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
A study testing speWHE and WHE in people with Diabetes Mellitus, Type 2, run by University of Aarhus at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- speWHE and WHE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Jan 2020to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
Aarhus
About this study
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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- speWHE, WHE
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speWHEDietary supplement
25 gram of a specific whey fraction (confidential)
WHEDietary supplement
25 gram protein of a regular whey compound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: speWHE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in iAUC for insulin between WHE and speWHE
Difference in iAUC for insulin between WHE and speWHE
Measured: OGTT, 3 hours.
Secondary outcomes (8)
Differences in iAUC and concentration differences for GIP
Measured: OGTT 3 hours
Differences in iAUC and concentration differences for GLP-1
Measured: OGTT 3 hours
Differences in iAUC and concentration differences for glucagon
Measured: OGTT 3 hours
Differences in iAUC and concentration differences for glucose
Measured: OGTT 3 hours
Differences in iAUC and concentration differences for C-peptid
Measured: OGTT 3 hours
Differences in iAUC and concentration differences for FFA
Measured: OGTT 3 hours
Activity measurements
Measured: 5 days
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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start6 Jan 2020
- Primary completion17 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blinded, randomized, crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niels Jessen, Professor, Study director, Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166760
- Sponsor's protocol ID
- TAKE4
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
- ClinicalTrials.gov ID
- NCT04166760
- Acronym / sponsor ID
- TAKE4
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blinded, randomized, crossover design
| Arm | Type | Receives |
|---|---|---|
| WHE (regular whey protein) | Active comparator | Dietary Supplement: WHERegular 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) | Experimental | Dietary Supplement: speWHESpecific 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| speWHE25 gram of a specific whey fraction (confidential) | Dietary supplement | speWHE (specific whey protein compound) |
| WHE25 gram protein of a regular whey compound | Dietary supplement | WHE (regular whey protein) |
Primary outcome
Difference in iAUC for insulin between WHE and speWHE
Time frame: OGTT, 3 hours.
Difference in iAUC for insulin between WHE and speWHE
8 secondary outcomes
Differences in iAUC and concentration differences for GIP
Time frame: OGTT 3 hours
Differences in iAUC and concentration differences for GLP-1
Time frame: OGTT 3 hours
Differences in iAUC and concentration differences for glucagon
Time frame: OGTT 3 hours
Differences in iAUC and concentration differences for glucose
Time frame: OGTT 3 hours
Differences in iAUC and concentration differences for C-peptid
Time frame: OGTT 3 hours
Differences in iAUC and concentration differences for FFA
Time frame: OGTT 3 hours
Activity measurements
Time frame: 5 days
continuous glucose measurement (CGM)
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Jessen, Professor study director
Medicinsk forskningslaboratorium for Diabetes og Hormonsygdomme og Steno Diabetes Center Aarhus (M-lab), Aarhus universitetshospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing speWHE and WHE in people with Diabetes Mellitus, Type 2, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in iAUC for insulin between WHE and speWHE (time frame: OGTT, 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.