Type 2 Diabetes MellitusPhase 1/2PMB/T2DNCT01987674
Pre-meal Protein Drink Improve Glycemic Regulation
A Phase 1/2 study testing Pre-meal protein drink and Water drink in people with Type 2 Diabetes Mellitus, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Pre-meal protein drink and Water drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Jul 2015
- Phase
- Phase 1/2
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
- age between 30-80 years
- non well controlled diabetes with HbA1c-levels above 62 mmol/mol
Who cannot join
- pregnant or risk of becoming pregnant
- severe disease
- psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
- liver disease
- kidney malfunction (GFR <60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes
The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Pre-meal protein drink, Water drink
- 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.
Pre-meal protein drinkDietary supplement
Water drinkOther
| Study group | Role | What they receive |
|---|---|---|
| Pre-meal protein drink | Experimental | A dose of 100 ml is taken just before breakfast, lunch and dinner. Receives: Dietary Supplement: Pre-meal protein drink |
| Water drink | Placebo comparator | A dose of 100 ml is taken just before breakfast, lunch and dinner. Receives: Other: Water drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Glycated hemoglobin
Measured: 16 weeks
Secondary outcomes (1)
Postprandial glycemia
Meal challenge given at start and end of study with repeated blood glucose sampling over 2h.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Test products expired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Landstinget i Kalmar Län
- Responsible party
- Principal investigator, Elin Östman, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987674
- Sponsor's protocol ID
- Dnr2013/239-31PMB
- Acronym
- PMB/T2D
- Status last verified
- May 2016
- First submitted
- 12 Nov 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01987674
- Acronym / sponsor ID
- PMB/T2D / Dnr2013/239-31PMB
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Test products expired.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Landstinget i Kalmar Län
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 19 Nov 2013 (estimated)
- 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 purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-meal protein drink | Experimental | Dietary Supplement: Pre-meal protein drinkA dose of 100 ml is taken just before breakfast, lunch and dinner. |
| Water drink | Placebo comparator | Other: Water drinkA dose of 100 ml is taken just before breakfast, lunch and dinner. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
- age between 30-80 years
- non well controlled diabetes with HbA1c-levels above 62 mmol/mol
Key exclusion criteria (5 listed)
- pregnant or risk of becoming pregnant
- severe disease
- psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
- liver disease
- kidney malfunction (GFR <60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
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 |
|---|---|---|
| Pre-meal protein drink | Dietary supplement | Pre-meal protein drink |
| Water drink | Other | Water drink |
Primary outcome
HbA1c
Time frame: 16 weeks
Glycated hemoglobin
1 secondary outcome
Postprandial glycemia
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Test products expired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pre-meal protein drink and Water drink in people with Type 2 Diabetes Mellitus, run by Lund University at 1 site in Sweden.
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 3 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: stopped early, as of the sponsor's last update on 12 May 2016. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Test products expired.). Results are not available in the source record.
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?
HbA1c (time frame: 16 weeks). 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 12 May 2016.