Type 2 Diabetes MellitusAVSNCT02230501
Metabolic Activation With Protein-rich Formula Diet
A study testing stringent diet regimen and moderate diet regimen in people with Type 2 Diabetes Mellitus, run by West German Center of Diabetes and Health at 1 site in Germany.
Trial summary
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. Read more about this study
- Who is it for?
- Ages 25 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- stringent diet regimen and moderate diet regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to 31 Dec 2023
- 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 25 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- HbA1c > 7,5%
- Body Mass Index (BMI) ≥ 27,5 kg/m2
Who cannot join
- acute infections
- severe diseased with hospital stay during the last 3 months
- chronic diseases
- chemotherapy or cortisone treatment
- weight loss of more than 2 kg per week during the last month
- smoking cessation during the last 3 months or planned
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- weight-influencing medication
- pregnancy, breast-feeding or lack of contraception
- high-level physical activity of more than 1h per day
- incompatibility with components of the PRMR
- participation in an other study during the last 6 months
- For the open-label registry, the only inclusion criterium is type 2 diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.
A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.
Read the detailed description
Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.
In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- stringent diet regimen, moderate diet regimen
- 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.
stringent diet regimenDietary supplement
Also called protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
moderate diet regimenDietary supplement
Also called protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany)
| Study group | Role | What they receive |
|---|---|---|
| moderate diet regimen | Experimental | Week 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned. Receives: Dietary Supplement: moderate diet regimen |
| stringent diet regimen | Experimental | Week 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner
For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned. Receives: Dietary Supplement: stringent diet regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
change in hemoglobin A1c
Measured: 12 weeks
Secondary outcomes (9)
HbA1c
change in hemoglobin A1c
Measured: 1 year
body weight
change in body weight
Measured: 12 weeks and 1 year
blood pressure
change in systolic and diastolic blood pressure
Measured: 12 weeks and 1 year
cholesterol
change in total cholesterol change in HDL cholesterol change in LDL cholesterol
Measured: 12 weeks and 1 year
fasting blood glucose
change in fastin g blood glucose
Measured: 12 weeks and 1 year
quality of life
change in SF-36 quality of life questionnaire change in ADS-L (German version of the general depression scale)
Measured: 12 weeks and 1 year
nutrition
change in FEV (questionnaire for eating manners)
Measured: 12 weeks and 1 year
physical activity
change in physical activity questionnaire
Measured: 12 weeks and 1 year
antidiabetic medication
- absolute amount of antidiabetic medication
- increase or reduction
Measured: 12 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startFeb 2011
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the second part of the study, i.e. the open-label registry, there ist no randomization.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230501
- Sponsor's protocol ID
- AVS
- Acronym
- AVS
- Status last verified
- Jan 2024
- First submitted
- 26 Aug 2014
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Activation With Protein-rich Formula Diet - a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02230501
- Acronym / sponsor ID
- AVS / AVS
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Collaborators
- Almased Wellness GmbH
- Study start
- Feb 2011 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Sep 2014 (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.
Formerly, the investigators demonstrated in an uncontrolled proof-of principle study (NCT 01680926) that protein-rich meal replacement (PRMR) was successful in reducing daily insulin demand, HbA1c and weight in type 2 diabetes mellitus (T2DM) patients injecting >100 IE insulin/day. The aim of the present study was to investigate in a randomized-controlled trial if PRMR is also effective in T2DM patients treated with oral antidiabetic medication or insulin.
A second part of the study is an open-label registry for persons with type 2 diabetes, who will perform the lifestyle intervention with the stringent diet regime.
Detailed description
Type 2 diabetes mellitus (T2DM) patients had been randomized into two groups. During the 1st week the intervention group with stringent diet regime replaced 3 main meals by 50 g PRMR (Almased-Vitalkost, Almased Wellness GmbH, Bienenbüttel, Germany) each (=1100 kcal/day). In 2nd-4th week 2 meals were replaced and a protein-rich lunch was allowed. In 5th-12th week only dinner was replaced. The control group with moderate diet regime replaced breakfast and dinner for 4 weeks and then only dinner during the next 8 weeks. Clinical parameters were determined at the study center at baseline, after 4, 8 and 12 weeks. Primary endpoint was reduction of HbA1c, secondary endpoints reduction of weight and antidiabetic medication.
In the second part of the study type 2 diabetes patients are included in an open-label reistry and perform the lifestyle intervention with the stringent diet regime.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- For the second part of the study, i.e. the open-label registry, there ist no randomization.
| Arm | Type | Receives |
|---|---|---|
| moderate diet regimen | Experimental | Dietary Supplement: moderate diet regimenWeek 1-4: replacement of breakfast and dinner with 1g PRMR /kg normal weight (=height in cm-100), a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned. |
| stringent diet regimen | Experimental | Dietary Supplement: stringent diet regimenWeek 1: replacement of 3 main meals by 1g PRMR / kg normal weight (=height in cm - 100) Week 2-4: replacement of breakfast and dinner, a protein-rich lunch was allowed Week 5-12: replacement of dinner For this arm a local subgroup (n=55) and a nation-wide subgroup (n=100) is planned. |
Who may qualify
- Ages
- 25 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- HbA1c > 7,5%
- Body Mass Index (BMI) ≥ 27,5 kg/m2
Key exclusion criteria (12 listed)
- acute infections
- severe diseased with hospital stay during the last 3 months
- chronic diseases
- chemotherapy or cortisone treatment
- weight loss of more than 2 kg per week during the last month
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 |
|---|---|---|
| stringent diet regimenAlso: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany) | Dietary supplement | stringent diet regimen |
| moderate diet regimenAlso: protein-rich meal replacement (PRMR), i.e Almased-Vitalkost (Almased Wellness GmbH, Bienenbüttel, Germany) | Dietary supplement | moderate diet regimen |
Primary outcome
HbA1c
Time frame: 12 weeks
change in hemoglobin A1c
9 secondary outcomes
HbA1c
Time frame: 1 year
body weight
Time frame: 12 weeks and 1 year
blood pressure
Time frame: 12 weeks and 1 year
cholesterol
Time frame: 12 weeks and 1 year
fasting blood glucose
Time frame: 12 weeks and 1 year
quality of life
Time frame: 12 weeks and 1 year
nutrition
Time frame: 12 weeks and 1 year
physical activity
Time frame: 12 weeks and 1 year
antidiabetic medication
Time frame: 12 weeks and 1 year
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 23 Jan 2024.
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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 study testing stringent diet regimen and moderate diet regimen 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 3 inclusion and 12 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 23 Jan 2024. 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.
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?
HbA1c (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 23 Jan 2024.