DiabetesBRAAWONCT03261362
Impact of Branched-chain Amino Acids in the Development of Insulin Resistance
A study testing Branched-chain amino acids reduced intake in people with Diabetes, run by German Diabetes Center at 1 site in Germany.
Trial summary
The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Branched-chain amino acids reduced intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to 31 Dec 2019
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diabetes type 2
- Non smokers
- Untrained
- Willingness to adhere to a diet intervention
Who cannot join
- Chronic disease
- Pregnancy
- Cancer
- Antibiotic therapy
- Drug/alcohol abuse
- Competitive athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes
The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes
Read the detailed description
The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.
The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status
- Conditions
- Diabetes
- Being tested
- Branched-chain amino acids reduced intake
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched-chain amino acids reduced intakeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Amino acid powder with all amino acids | Placebo comparator | amino acid powder 80 g oral Administration 1 week Receives: Dietary Supplement: Branched-chain amino acids reduced intake |
| Amino acid powder without BCAAs-reduced intake | Active comparator | Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week - Receives: Dietary Supplement: Branched-chain amino acids reduced intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clamp test
Insulin sensitivity test
Measured: up to 24 weeks
Secondary outcomes (1)
Mixed Meal Test
B cell function test
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study startMar 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roden, MD, Principal investigator, Deutsches Diabetes Zentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261362
- Sponsor's protocol ID
- 2014092783
- Acronym
- BRAAWO
- Status last verified
- Jun 2023
- First submitted
- 22 Aug 2017
- Last updated
- 5 Jun 2023
- Results posted
- No
Publications
Karusheva Y, Koessler T, Strassburger K, Markgraf D, Mastrototaro L, Jelenik T, Simon MC, Pesta D, Zaharia OP, Bodis K, Barenz F, Schmoll D, Wolkersdorfer M, Tura A, Pacini G, Burkart V, Mussig K, Szendroedi J, Roden M. Short-term dietary reduction of branched-chain amino acids reduces meal-induced insulin secretion and modifies microbiome composition in type 2 diabetes: a randomized controlled crossover trial. Am J Clin Nutr. 2019 Nov 1;110(5):1098-1107. doi: 10.1093/ajcn/nqz191.
PubMed 31667519
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03261362
- Acronym / sponsor ID
- BRAAWO / 2014092783
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Aug 2017 (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 purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes
Detailed description
The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.
The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino acid powder with all amino acids | Placebo comparator | Dietary Supplement: Branched-chain amino acids reduced intakeamino acid powder 80 g oral Administration 1 week |
| Amino acid powder without BCAAs-reduced intake | Active comparator | Dietary Supplement: Branched-chain amino acids reduced intakeBranched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week - |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diabetes type 2
- Non smokers
- Untrained
- Willingness to adhere to a diet intervention
Key exclusion criteria (6 listed)
- Chronic disease
- Pregnancy
- Cancer
- Antibiotic therapy
- Drug/alcohol abuse
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 |
|---|---|---|
| Branched-chain amino acids reduced intake | Dietary supplement | Amino acid powder with all amino acids, Amino acid powder without BCAAs-reduced intake |
Primary outcome
Clamp test
Time frame: up to 24 weeks
Insulin sensitivity test
1 secondary outcome
Mixed Meal Test
Time frame: up to 24 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 5 Jun 2023.
- Derived from this study: PubMed 31667519Karusheva Y, Koessler T, Strassburger K, Markgraf D, Mastrototaro L, Jelenik T, Simon MC, Pesta D, Zaharia OP, Bodis K, Barenz F, Schmoll D, Wolkersdorfer M, Tura A, Pacini G, Burkart V, Mussig K, Szendroedi J, Roden M. Short-term dietary reduction of branched-chain amino acids reduces meal-induced insulin secretion and modifies microbiome composition in type 2 diabetes: a randomized controlled crossover trial. Am J Clin Nutr. 2019 Nov 1;110(5):1098-1107. doi: 10.1093/ajcn/nqz191.
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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.
Michael Roden, MD principal investigator
Deutsches Diabetes Zentrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branched-chain amino acids reduced intake in people with Diabetes, run by German Diabetes Center 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 6 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 5 Jun 2023. 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. 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.
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?
Clamp test (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261362, which also lists 1 linked publication.
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 5 Jun 2023.