Diabetes Mellitus, Type 2NCT05129735
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
A study testing Meal replacement shake in people with Diabetes Mellitus, Type 2, run by Teatis, Inc at 1 site in United States.
Trial summary
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Meal replacement shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 30 Dec 2022
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female between 18-75 years old
- Diagnosed with type 2 diabetes for at least 3 months
- HbA1c of 7.5 to 10% inclusive
- BMI of 27 to 40 kg/m2
- If on any medication, treated with a stable dose for at least 90 days
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Willing and able to provide written informed consent
- Must have a Glucometer at home
Who cannot join
- Diagnosis of type 1 diabetes
- Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
- Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
- Allergies to any test product ingredients
- Has any of the following medical conditions:
- Oncological conditions
Show all 16Show fewer
- Psychiatric disease
- Cardiovascular disease: any hospitalization within the past 3 months
- Multiple Sclerosis
- Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
- Any other severe chronic disease
- History of drug or alcohol abuse
- Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
- Participation in a clinical research trial within 30 days prior to screening
- Participating in an investigational health product research study
- Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Meal replacement shake
- 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.
Meal replacement shakeDietary supplement
Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely.
| Study group | Role | What they receive |
|---|---|---|
| Meal replacement shake | Experimental | Teatis meal replacement shake Receives: Dietary Supplement: Meal replacement shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of quality of life score from baseline to 12-weeks
Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)
Measured: 12 weeks
Secondary outcomes (7)
Improvement in a1c levels from baseline to 12-weeks
Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in blood glucose from baseline to 12-weeks
Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in insulin levels from baseline to 12-weeks
Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in total cholesterol levels from baseline to 12-weeks
Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in triglyceride levels from baseline to 12-weeks
Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in HDL cholesterol levels from baseline to 12-weeks
Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Measured: 12 weeks
Improvement in LDL cholesterol levels from baseline to 12-weeks
Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
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 posted22 Nov 2021
- Study start15 Sep 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Sponsor withdrawn
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label single-arm observational trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teatis, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, MSc, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129735
- Sponsor's protocol ID
- 20227Teatis
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2021
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
- ClinicalTrials.gov ID
- NCT05129735
- Acronym / sponsor ID
- 20227Teatis
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Teatis, IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Nov 2021 (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.
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label single-arm observational trial
| Arm | Type | Receives |
|---|---|---|
| Meal replacement shake | Experimental | Dietary Supplement: Meal replacement shakeTeatis meal replacement shake |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female between 18-75 years old
- Diagnosed with type 2 diabetes for at least 3 months
- HbA1c of 7.5 to 10% inclusive
- BMI of 27 to 40 kg/m2
- If on any medication, treated with a stable dose for at least 90 days
Key exclusion criteria (16 listed)
- Diagnosis of type 1 diabetes
- Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
- Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
- Allergies to any test product ingredients
- Has any of the following medical conditions:
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 |
|---|---|---|
| Meal replacement shakeEach day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely. | Dietary supplement | Meal replacement shake |
Primary outcome
Improvement of quality of life score from baseline to 12-weeks
Time frame: 12 weeks
Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)
7 secondary outcomes
Improvement in a1c levels from baseline to 12-weeks
Time frame: 12 weeks
Improvement in blood glucose from baseline to 12-weeks
Time frame: 12 weeks
Improvement in insulin levels from baseline to 12-weeks
Time frame: 12 weeks
Improvement in total cholesterol levels from baseline to 12-weeks
Time frame: 12 weeks
Improvement in triglyceride levels from baseline to 12-weeks
Time frame: 12 weeks
Improvement in HDL cholesterol levels from baseline to 12-weeks
Time frame: 12 weeks
Improvement in LDL cholesterol levels from baseline to 12-weeks
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Susanne Mitschke, MSc principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal replacement shake in people with Diabetes Mellitus, Type 2, run by Teatis, Inc at 1 site in United States.
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 8 inclusion and 16 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: withdrawn, as of the sponsor's last update on 23 Aug 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement of quality of life score from baseline to 12-weeks (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 Aug 2024.