ObesityDRSNCT05397028
Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
A study testing Meal replacement system and Intensive lifestyle Intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Loma Linda University at 1 site in United States.
Trial summary
A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in >30% of intervention subjects To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- Meal replacement system and Intensive lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to 14 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women
- Ages 25-65
- Have been diagnosed with non-insulin dependent diabetes for less than five years
- Are taking at least one oral agents for diabetes
- English speaking
Who cannot join
- Individuals currently being treated for cancer
- Had a myocardial infarction in the previous 3 months
- Have uncontrolled persistent hypertension - diastolic >90 systolic >160
- Individuals with established eating disorder diagnoses
- Individuals who have recent weight loss attempt in the last 3 months with > 5-pound loss
- Use of anti-obesity medications in the last three months
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- Individuals who have had bariatric surgery
- Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
- Individuals who are pregnant or planning to become pregnant in the next 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92350
About this study
A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in >30% of intervention subjects
To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Being tested
- Meal replacement system, Intensive lifestyle Intervention
- Keywords
- obesity, Diabetes, Type 2, meal replacement, diabetes remission
- Medical subject headings
- Obesity, 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 systemDietary supplement
Participants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels).
Intensive lifestyle InterventionBehavioural
Participants will sign up with a virtual health program which they will interact with.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Replace meals with a plant-based meal replacement and self-prepared Meditteranean meals for a max 1200 calorie per day. Enroll in a 12 week intensive lifestyle intervention program. Receives: Dietary Supplement: Meal replacement system; Behavioral: Intensive lifestyle Intervention |
| Standard of Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of plant-based meal replacement system on A1-C levels
Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.
Measured: Change between baseline and six month visit.
Secondary outcomes (1)
Efficacy of plant-based meal replacement system on insulin levels
Blood draw to measure the effect of the diet on fasting insulin. Insulin levels under the value 10 are considered normal.
Measured: Change between baseline and six month visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start8 Dec 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Why it stopped: Unable to recruit sufficient number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren Peters, MD, MPH, Loma Linda University
- Investigators
- Warren Peters, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397028
- Sponsor's protocol ID
- 5200281
- Acronym
- DRS
- Status last verified
- Jan 2024
- First submitted
- 25 May 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)
- ClinicalTrials.gov ID
- NCT05397028
- Acronym / sponsor ID
- DRS / 5200281
- Conditions
- Obesity, Diabetes Mellitus, Type 2
- Keywords
- obesity, Diabetes, Type 2, meal replacement, diabetes remission
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient number of subjects
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 31 May 2022 (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.
A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in >30% of intervention subjects
To assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Meal replacement system, Behavioral: Intensive lifestyle InterventionReplace meals with a plant-based meal replacement and self-prepared Meditteranean meals for a max 1200 calorie per day. Enroll in a 12 week intensive lifestyle intervention program. |
| Standard of Care Group | No intervention | – |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and Women
- Ages 25-65
- Have been diagnosed with non-insulin dependent diabetes for less than five years
- Are taking at least one oral agents for diabetes
- English speaking
Key exclusion criteria (9 listed)
- Individuals currently being treated for cancer
- Had a myocardial infarction in the previous 3 months
- Have uncontrolled persistent hypertension - diastolic >90 systolic >160
- Individuals with established eating disorder diagnoses
- Individuals who have recent weight loss attempt in the last 3 months with > 5-pound loss
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 systemParticipants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels). | Dietary supplement | Intervention Group |
| Intensive lifestyle InterventionParticipants will sign up with a virtual health program which they will interact with. | Behavioural | Intervention Group |
Primary outcome
Efficacy of plant-based meal replacement system on A1-C levels
Time frame: Change between baseline and six month visit.
Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.
1 secondary outcome
Efficacy of plant-based meal replacement system on insulin levels
Time frame: Change between baseline and six month visit.
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient number of subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Warren Peters, MD principal investigator
Loma Linda University Health
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 system and Intensive lifestyle Intervention in people with Obesity and Diabetes Mellitus, Type 2, run by Loma Linda University 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 5 inclusion and 9 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 19 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 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 stopped early (reason given: Unable to recruit sufficient number of subjects). 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?
Efficacy of plant-based meal replacement system on A1-C levels (time frame: Change between baseline and six month visit.). 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 19 Jan 2024.