Diabetes Mellitus, Type 2Phase 1/2NCT02791867
Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake
A Phase 1/2 study testing AphoelineBrake in people with Diabetes Mellitus, Type 2, run by Dasman Diabetes Institute at 1 site in Kuwait.
Trial summary
The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- AphoelineBrake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteKuwait
- Study dates
- Dec 2014to Jul 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥21 years
- Diagnosis of T2DM
- Metformin as first line treatment
- HbA1c ≥7
- Calculated HOMA-IR ≥3.0,
- BMI 25-45
- Triglyceride level ≥ 2.26 mmol/L
Who cannot join
- Age <21 years of age
- BMI ≤ 25
- Pregnant
- Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
- Subjects treated with Liraglutide (Victoza®).
- Renal, hepatic or cardiac failure.
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- Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™
- Subjects diagnosed with Irritable Bowel Syndrome.
- Subjects diagnosed with Ulcerative Colitis or Crohn's disease.
- History of significant gastrointestinal disease.
- Poor venous access.
- Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- AphoelineBrake
- 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.
AphoelineBrakeDrug
The study is proposed as a placebo controlled randomized controlled trial with an intervention (AphoelineBrake) in addition to their standard treatment in comparison to a standard treatment control arm receiving an identical placebo. Prior to the commencement of any study procedures, participants will document informed consent and acknowledgement of privacy rights. Participants will be seen for initial consenting procedures, initial study procedures, and follow-up procedures at the Dasman Diabetes Institute clinic.Scheduled study visits will occur at Day 0, Day 7, Months: 1, 3, 6, 9, and 12 months in accordance with standards of medical care.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | AphoelineBrake administration Receives: Drug: AphoelineBrake |
| Placebo | Placebo comparator | Placebo Administration Receives: Drug: AphoelineBrake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Insulin Resistance measured by HOMA-IR
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.
Measured: 12 months from intervention
Reduction in glycated Haemoglobin measured: HBA1c
HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.
Measured: 12 months from intervention
Secondary outcomes (1)
Reduction in serum triglyceride level (mmol/l)
Measured: 12 months from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: The study drug was not provided resulting in termination for unacceptable delays
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dasman Diabetes Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Nadia Zghoul, PhD, Principal investigator, Dasman Diabetes InstituteJerome Schentag, PharmD, Principal investigator, University at Buffalo, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791867
- Sponsor's protocol ID
- RA 2014-019
- Status last verified
- Dec 2016
- First submitted
- 12 May 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake
- ClinicalTrials.gov ID
- NCT02791867
- Acronym / sponsor ID
- RA 2014-019
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study drug was not provided resulting in termination for unacceptable delays
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dasman Diabetes InstituteUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 7 Jun 2016 (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 primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: AphoelineBrakeAphoelineBrake administration |
| Placebo | Placebo comparator | Drug: AphoelineBrakePlacebo Administration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥21 years
- Diagnosis of T2DM
- Metformin as first line treatment
- HbA1c ≥7
- Calculated HOMA-IR ≥3.0,
Key exclusion criteria (12 listed)
- Age <21 years of age
- BMI ≤ 25
- Pregnant
- Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.
- Subjects treated with Liraglutide (Victoza®).
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 |
|---|---|---|
| AphoelineBrakeThe study is proposed as a placebo controlled randomized controlled trial with an intervention (AphoelineBrake) in addition to their standard treatment in comparison to a standard treatment control arm receiving an identical placebo. Prior to the commencement of any study procedures, participants will document informed consent and acknowledgement of privacy rights. Participants will be seen for initial consenting procedures, initial study procedures, and follow-up procedures at the Dasman Diabetes Institute clinic.Scheduled study visits will occur at Day 0, Day 7, Months: 1, 3, 6, 9, and 12 months in accordance with standards of medical care. | Drug | Active, Placebo |
Primary outcome
Reduction in Insulin Resistance measured by HOMA-IR
Time frame: 12 months from intervention
Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.
Reduction in glycated Haemoglobin measured: HBA1c
Time frame: 12 months from intervention
HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.
1 secondary outcome
Reduction in serum triglyceride level (mmol/l)
Time frame: 12 months from intervention
Results and safety
The study was stopped early (reason given: The study drug was not provided resulting in termination for unacceptable delays). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
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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.
Nadia Zghoul, PhD principal investigator
Dasman Diabetes Institute
Jerome Schentag, PharmD principal investigator
University at Buffalo, New York
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 AphoelineBrake in people with Diabetes Mellitus, Type 2, run by Dasman Diabetes Institute at 1 site in Kuwait.
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 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: stopped early, as of the sponsor's last update on 27 Nov 2018. 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 Kuwait. 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: The study drug was not provided resulting in termination for unacceptable delays). 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?
Reduction in Insulin Resistance measured by HOMA-IR (time frame: 12 months from intervention). The study lists 2 primary outcomes in all. 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 27 Nov 2018.