Diabetes Mellitus, Type 2FAME-HNCT05026723
Food as Medicine for HIV and Diabetes
A study testing MTM + ILI and Standard MTM in people with Diabetes Mellitus, Type 2 and HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes
- What is being tested?
- MTM + ILI and Standard MTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Diagnosis of HIV
- Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus, defined as meeting CDC eligibility criteria for the diabetes prevention program. Specifically, an individual without a diagnosis of T2DM must 1) have had a blood test result in the prediabetes range within the past year (Hemoglobin A1C: 5.7-6.4% OR Fasting plasma glucose: 100-125 mg/dL OR Two-hour plasma glucose [after a 75 g glucose load]: 140-199 mg/dL), 2) Have been previously diagnosed with gestational diabetes, OR 3) have a high-risk result (score of 5 or higher) on the Prediabetes Risk Test (https://www.cdc.gov/prediabetes/pdf/Prediabetes-Risk-Test-Final.pdf)
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- Aged ≥18 years
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- BMI ≥ 23 kg/m2
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Willing and able to provide written informed consent and participate in all study activities
Who cannot join
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Current AIDS defining illness
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
- Lack of telephone
Show all 12Show fewer
- Pregnancy/breastfeeding or intended pregnancy in the next year
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured > 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- Advanced kidney disease (estimated creatinine clearance < 30 ml/min)
- Known drug or alcohol misuse in the past 6 months
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.
Read the detailed description
In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, "lack of access to enough food for an active, healthy life", is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications.
Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV.
The investigators has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention.
Thus, the investigators propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM or high risk for T2DM, referred for medically tailored meals. Adults with hemoglobin A1c less than 12.0%, and BMI ≥ 23 kg/m^2 will be enrolled and randomly assigned to intervention or standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is weight at 6 months. Secondary outcomes include hemoglobin a1c, food security, quality of life, and diabetes distress.
- Conditions
- Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes
- Being tested
- MTM + ILI, Standard MTM
- Keywords
- Food Insecurity, Socioeconomic Factors, Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, HIV Infections, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTM + ILIBehavioural
Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program
Standard MTMBehavioural
Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian
| Study group | Role | What they receive |
|---|---|---|
| Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) | Experimental | The Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. Receives: Behavioral: MTM + ILI |
| Standard MTM | Active comparator | The Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian. Receives: Behavioral: Standard MTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bodyweight at Month 6
Bodyweight measured in Kg
Measured: 6 months
Secondary outcomes (14)
Bodyweight at Month 12
Bodyweight measured in Kg
Measured: 12 months
Bodyweight at Month 18
Bodyweight measured in Kg
Measured: 18 months
Hemoglobin A1c at Month 6
Hemoglobin A1c Level
Measured: 6 months
Hemoglobin A1c at Month 12
Hemoglobin A1c Level
Measured: 12 months
Hemoglobin A1c at Month 18
Hemoglobin A1c Level
Measured: 18 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 6 months
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 12 months
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms. Will report overall score and scores for each domain. From these data will also calculate a PROMIS-Preference (PROPr score) (PROPr scores range from -0.022 (worst) to 1.0 (best)).
Measured: 18 months
Depressive Symptom Score at Month 6
Depressive Symptoms as assessed by PROMIS Short Form (PROMIS SF) v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Measured: 6 months
Depressive Symptom Score at Month 12
Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Measured: 12 months
Depressive Symptom Score at Month 18
Depressive Symptoms as assessed by PROMIS SF v1.0 - Depression 4a. Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on depression indicates more severe depressive symptoms.
Measured: 18 months
Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6
Score ranges from 11-55 with higher scores indicating greater diabetes distress
Measured: 6 months
Diabetes Distress Score as assessed by PAID-11 at Month 12
Score ranges from 11-55 with higher scores indicating greater diabetes distress
Measured: 12 months
Diabetes Distress Score as assessed by PAID-11 at Month 18
Score ranges from 11-55 with higher scores indicating greater diabetes distress
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start4 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionApr 2027 (estimated)
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.
- More trials run by University of North Carolina, Chapel HillThe 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
- Model description
- Participants will be assigned in 1:1 ratio to one of two intervention arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Community Servings, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Seth A Berkowitz, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026723
- Sponsor's protocol ID
- 20-3509
- Other IDs
- R01DK127365
- Acronym
- FAME-H
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2021
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT05026723
- Acronym / sponsor ID
- FAME-H / 20-3509
- Conditions
- Diabetes Mellitus, Type 2, HIV Infections, PreDiabetes
- Keywords
- Food Insecurity, Socioeconomic Factors, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Community Servings, Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 30 Aug 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 a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.
Detailed description
In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, "lack of access to enough food for an active, healthy life", is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications.
Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV.
The investigators has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in weight, hemoglobin A1c, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention.
Thus, the investigators propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM or high risk for T2DM, referred for medically tailored meals. Adults with hemoglobin A1c less than 12.0%, and BMI ≥ 23 kg/m^2 will be enrolled and randomly assigned to intervention or standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is weight at 6 months. Secondary outcomes include hemoglobin a1c, food security, quality of life, and diabetes distress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in 1:1 ratio to one of two intervention arms
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) | Experimental | Behavioral: MTM + ILIThe Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention. |
| Standard MTM | Active comparator | Behavioral: Standard MTMThe Standard Medically Tailored Meal (MTM) intervention (ILI) consists of weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Diagnosis of HIV
- Diagnosis of Type 2 Diabetes Mellitus or high risk for type 2 diabetes mellitus, defined as meeting CDC eligibility criteria for the diabetes prevention program. Specifically, an individual without a diagnosis of T2DM must 1) have had a blood test result in the prediabetes range within the past year (Hemoglobin A1C: 5.7-6.4% OR Fasting plasma glucose: 100-125 mg/dL OR Two-hour plasma glucose [after a 75 g glucose load]: 140-199 mg/dL), 2) Have been previously diagnosed with gestational diabetes, OR 3) have a high-risk result (score of 5 or higher) on the Prediabetes Risk Test (https://www.cdc.gov/prediabetes/pdf/Prediabetes-Risk-Test-Final.pdf)
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
Key exclusion criteria (12 listed)
- Participant in diabetes, nutrition, or weight research intervention in last 12 months
- Current AIDS defining illness
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery in the past 2 years
- Lack of safe, stable residence and ability to store meals
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 |
|---|---|---|
| MTM + ILIWeekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program | Behavioural | Medically Tailored Meal (MTM) + Intensive Lifestyle Intervention (ILI) |
| Standard MTMWeekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian | Behavioural | Standard MTM |
Primary outcome
Bodyweight at Month 6
Time frame: 6 months
Bodyweight measured in Kg
14 secondary outcomes
Bodyweight at Month 12
Time frame: 12 months
Bodyweight at Month 18
Time frame: 18 months
Hemoglobin A1c at Month 6
Time frame: 6 months
Hemoglobin A1c at Month 12
Time frame: 12 months
Hemoglobin A1c at Month 18
Time frame: 18 months
Health-Related Quality of Life Score as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-29 at Month 6
Time frame: 6 months
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 12
Time frame: 12 months
Health-Related Quality of Life Score as assessed by PROMIS-29 at Month 18
Time frame: 18 months
Depressive Symptom Score at Month 6
Time frame: 6 months
Depressive Symptom Score at Month 12
Time frame: 12 months
Depressive Symptom Score at Month 18
Time frame: 18 months
Diabetes Distress Score as assessed by Problem Areas in Diabetes (PAID)-11 at Month 6
Time frame: 6 months
Diabetes Distress Score as assessed by PAID-11 at Month 12
Time frame: 12 months
Diabetes Distress Score as assessed by PAID-11 at Month 18
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that can be deidentified without risk of confidentiality breach will shared upon written request made to study investigators. In addition, all NIH policies regarding data sharing will be followed. Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill (UNC).
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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.
Seth A Berkowitz, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM + ILI and Standard MTM in people with Diabetes Mellitus, Type 2 and HIV Infections, run by University of North Carolina, Chapel Hill 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 10 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Bodyweight at Month 6 (time frame: 6 months). 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 1 Sep 2026.