Type 2 Diabetes MellitusEarly Phase 1Almased100NCT01680926
Metabolic Activation With Almased for Type 2 Diabetes Patients
A Early Phase 1 study testing Almased in people with Type 2 Diabetes Mellitus, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not achieve satisfying metabolic control. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Almased
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to Oct 2011
- Phase
- Early Phase 1
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with type 2 diabetes
- BMI > 27 kg/m2
- age 35-75 years
- insulin therapy >100 U insulin per day
Who cannot join
- contraindication for a calorie reduced diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day
Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.
Read the detailed description
The pilot study included patients with type 2 diabetes (n=22), that injected >100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Almased
- Keywords
- type 2 diabetes mellitus, insulin, hbA1c, body weight
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmasedDietary supplement
Also called Almased-Vitalkost
During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
| Study group | Role | What they receive |
|---|---|---|
| Almased | Experimental | During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Receives: Dietary Supplement: Almased |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin demand per day
daily insulin dosage
Measured: 12 weeks
Secondary outcomes (2)
HbA1c
HbA1c
Measured: 12 weeks
body weight
body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionOct 2011
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.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Almased Wellness GmbH
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
- Investigators
- Stepahn Martin, MD, Principal investigator, West German Center of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680926
- Sponsor's protocol ID
- Almased100
- Acronym
- Almased100
- Status last verified
- Sep 2012
- First submitted
- 4 Sep 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein-rich Meal Replacement Significantly Reduces Weight, HbA1c and Daily Insulin Requirement Long-term in Patients With Type 2 Diabetes Mellitus and >100 U Insulin Per Day
- ClinicalTrials.gov ID
- NCT01680926
- Acronym / sponsor ID
- Almased100 / Almased100
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, insulin, hbA1c, body weight
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- Almased Wellness GmbH
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 7 Sep 2012 (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.
Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.
Detailed description
The pilot study included patients with type 2 diabetes (n=22), that injected >100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Almased | Experimental | Dietary Supplement: AlmasedDuring the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with type 2 diabetes
- BMI > 27 kg/m2
- age 35-75 years
- insulin therapy >100 U insulin per day
Key exclusion criteria (1 listed)
- contraindication for a calorie reduced diet
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 |
|---|---|---|
| AlmasedAlso: Almased-VitalkostDuring the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. | Dietary supplement | Almased |
Primary outcome
insulin demand per day
Time frame: 12 weeks
daily insulin dosage
2 secondary outcomes
HbA1c
Time frame: 12 weeks
body weight
Time frame: 12 weeks
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 11 Sep 2012.
- Homepage WDGZLink provided by the sponsor.
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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.
Stepahn Martin, MD principal investigator
West German Center of Diabetes and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Almased in people with Type 2 Diabetes Mellitus, run by West German Center of Diabetes and Health at 1 site in Germany.
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 4 inclusion and 1 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 11 Sep 2012. 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 Germany. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
insulin demand per day (time frame: 12 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 11 Sep 2012.