Abnormal Glucose MetabolismNCT03545217
Abnormal Glucose Metabolism in HIV-infected Patients
A study testing Lifestyle Intervention in people with Abnormal Glucose Metabolism, run by Mahidol University at 1 site in Thailand.
Trial summary
HIV is a major health problem worldwide especially in low-to middle-income countries including Thailand. Fortunately, a significant reduction in morbidity and mortality has been observed due to the use of combination antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Abnormal Glucose Metabolism
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jul 2017to Jul 2020
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected patients, age 35-65 years old
- Receiving antiretroviral therapy
- Diagnosis of prediabetes (hemoglobin A1c, HbA1c levels ≥5.7-<6.5% and fasting glucose levels <126 mg/dl and 2-hour glucose levels <200 mg/dl following 75-gram OGTT)
Who cannot join
- Serious medical problems (stroke with significant disability, estimated glomerular filtration rate <45 ml/min/1.73 m2, uncontrolled congestive heart failure, symptoms suggestive of untreated cardiopulmonary disease such as chest pain or shortness of breath, significant anemia defined as hemoglobin <9.0 g/dL, severe pulmonary disease including those requiring home oxygen therapy, end stage liver disease)
- A previous diagnosis of diabetes
- Currently diagnosed with contagious infectious disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Sirimon R Pratuangtham, MD contact
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Bangkok, 10400
Piyamitr Sritara, MD
About this study
Official title: Abnormal Glucose Metabolism in HIV-infected Patients: Prevalence of Prediabetes, the Relationship to Gut Microbiota and Sleep, and the Role of Lifestyle Intervention
HIV is a major health problem worldwide especially in low-to middle-income countries including Thailand. Fortunately, a significant reduction in morbidity and mortality has been observed due to the use of combination antiretroviral therapy. As the natural history of the disease is modified, non-communicable diseases are becoming recognized complications of HIV infection, including insulin resistance, dyslipidemia and type 2 diabetes. The prevalence of type 2 diabetes in HIV-infected patients is significantly higher than in the general population, likely contributed by antiretroviral regimen and an ongoing, usually subclinical, inflammation. People with prediabetes, a condition which blood sugars are elevated but not yet meeting the criteria for diabetes, represent a high risk group for future diabetes development. Lifestyle interventions, including diet and exercise, are effective in reducing the future diabetes risk by as much as 58%, including in Thailand. The knowledge whether these interventions are effective in HIV-infected patients, given their unique characteristics, is not available at this time but urgently needed. Moreover, the program tailored to each country's local values, culture and socioeconomic status is essential as participants' acceptability is one of the keys to program's success. This current proposal will adapt a 6-month intensive lifestyle intervention program and evaluate its feasibility and acceptability in HIV-infected individuals with prediabetes in Thailand. The knowledge gained will be highly relevant for Thailand and for other low-to-middle-income countries. Furthermore, gut microbiota and insufficient sleep are novel factors shown to affect individual's metabolic health. Insufficient sleep is recognized as a risk factor for incident diabetes. Gut microbiota composition differs between those with and without diabetes. The current proposal will examine how gut microbiota and sleep duration differ between HIV-infected individuals with and without prediabetes, and now there change or modulate the metabolic response to the 6-month intensive lifestyle interventions. Lastly, HIV and diabetes are global epidemics, research capacity building among countries is essential to battle these health problems. This proposal will aim to build research capacities among three international institutions: University of Illinois at Chicago, Illinois, U.S.A.; Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand, one of the top medical schools in Thailand; and a newly formed medical school, Navamindradhiraj University, Vajira Hospital, Bangkok, Thailand. Through close collaboration, networking, in-person training and workshops, the proposed study will enhance research capacity and improve lives of those living with HIV.
- Conditions
- Abnormal Glucose Metabolism
- Being tested
- Lifestyle Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
a 6-month intensive lifestyle intervention program led by a multidisciplinary team of diabetes nurses and dieticians, and a follow up at 12 months for these participants. This will be a group-based activity adapted from the Diabetes Prevention Program -Thailand project
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: Lifestyle Intervention |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
new diabetes
occurrence of diabetes mellitus
Measured: 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start21 Jul 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abnormal Glucose MetabolismStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Somnuek Sungkanuparph, Mahidol University
- Investigators
- Somnuek Sungkanuparph, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545217
- Sponsor's protocol ID
- ID066011
- Status last verified
- May 2018
- First submitted
- 22 May 2018
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nimitphong H, Sungkanuparph S, Areevut C, Saetung S, Jerawatana R, Hathaidechadusadee A, Somwang S, Tongchom W, Saibuathong N, Sakmanarit J, Pichitchaipitak O, Phuphuakrat A, Reutrakul S. Effects of an intensive lifestyle intervention and the role of sleep in people living with HIV and prediabetes: a pilot and feasibility study. BMC Res Notes. 2021 Apr 17;14(1):145. doi: 10.1186/s13104-021-05558-z.
PubMed 33865450Phuphuakrat A, Nimitphong H, Reutrakul S, Sungkanuparph S. Prediabetes among HIV-infected individuals receiving antiretroviral therapy: prevalence, diagnostic tests, and associated factors. AIDS Res Ther. 2020 May 24;17(1):25. doi: 10.1186/s12981-020-00284-1.
PubMed 32448349
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Glucose Metabolism in HIV-infected Patients: Prevalence of Prediabetes, the Relationship to Gut Microbiota and Sleep, and the Role of Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT03545217
- Acronym / sponsor ID
- ID066011
- Conditions
- Abnormal Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 4 Jun 2018 (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.
HIV is a major health problem worldwide especially in low-to middle-income countries including Thailand. Fortunately, a significant reduction in morbidity and mortality has been observed due to the use of combination antiretroviral therapy. As the natural history of the disease is modified, non-communicable diseases are becoming recognized complications of HIV infection, including insulin resistance, dyslipidemia and type 2 diabetes. The prevalence of type 2 diabetes in HIV-infected patients is significantly higher than in the general population, likely contributed by antiretroviral regimen and an ongoing, usually subclinical, inflammation. People with prediabetes, a condition which blood sugars are elevated but not yet meeting the criteria for diabetes, represent a high risk group for future diabetes development. Lifestyle interventions, including diet and exercise, are effective in reducing the future diabetes risk by as much as 58%, including in Thailand. The knowledge whether these interventions are effective in HIV-infected patients, given their unique characteristics, is not available at this time but urgently needed. Moreover, the program tailored to each country's local values, culture and socioeconomic status is essential as participants' acceptability is one of the keys to program's success. This current proposal will adapt a 6-month intensive lifestyle intervention program and evaluate its feasibility and acceptability in HIV-infected individuals with prediabetes in Thailand. The knowledge gained will be highly relevant for Thailand and for other low-to-middle-income countries. Furthermore, gut microbiota and insufficient sleep are novel factors shown to affect individual's metabolic health. Insufficient sleep is recognized as a risk factor for incident diabetes. Gut microbiota composition differs between those with and without diabetes. The current proposal will examine how gut microbiota and sleep duration differ between HIV-infected individuals with and without prediabetes, and now there change or modulate the metabolic response to the 6-month intensive lifestyle interventions. Lastly, HIV and diabetes are global epidemics, research capacity building among countries is essential to battle these health problems. This proposal will aim to build research capacities among three international institutions: University of Illinois at Chicago, Illinois, U.S.A.; Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand, one of the top medical schools in Thailand; and a newly formed medical school, Navamindradhiraj University, Vajira Hospital, Bangkok, Thailand. Through close collaboration, networking, in-person training and workshops, the proposed study will enhance research capacity and improve lives of those living with HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Lifestyle Intervention |
| control group | No intervention | – |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-infected patients, age 35-65 years old
- Receiving antiretroviral therapy
- Diagnosis of prediabetes (hemoglobin A1c, HbA1c levels ≥5.7-<6.5% and fasting glucose levels <126 mg/dl and 2-hour glucose levels <200 mg/dl following 75-gram OGTT)
Key exclusion criteria (4 listed)
- Serious medical problems (stroke with significant disability, estimated glomerular filtration rate <45 ml/min/1.73 m2, uncontrolled congestive heart failure, symptoms suggestive of untreated cardiopulmonary disease such as chest pain or shortness of breath, significant anemia defined as hemoglobin <9.0 g/dL, severe pulmonary disease including those requiring home oxygen therapy, end stage liver disease)
- A previous diagnosis of diabetes
- Currently diagnosed with contagious infectious disease
- Pregnancy
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 |
|---|---|---|
| Lifestyle Interventiona 6-month intensive lifestyle intervention program led by a multidisciplinary team of diabetes nurses and dieticians, and a follow up at 12 months for these participants. This will be a group-based activity adapted from the Diabetes Prevention Program -Thailand project | Behavioural | intervention group |
Primary outcome
new diabetes
Time frame: 12 months after intervention
occurrence of diabetes mellitus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 33865450Nimitphong H, Sungkanuparph S, Areevut C, Saetung S, Jerawatana R, Hathaidechadusadee A, Somwang S, Tongchom W, Saibuathong N, Sakmanarit J, Pichitchaipitak O, Phuphuakrat A, Reutrakul S. Effects of an intensive lifestyle intervention and the role of sleep in people living with HIV and prediabetes: a pilot and feasibility study. BMC Res Notes. 2021 Apr 17;14(1):145. doi: 10.1186/s13104-021-05558-z.
- Derived from this study: PubMed 32448349Phuphuakrat A, Nimitphong H, Reutrakul S, Sungkanuparph S. Prediabetes among HIV-infected individuals receiving antiretroviral therapy: prevalence, diagnostic tests, and associated factors. AIDS Res Ther. 2020 May 24;17(1):25. doi: 10.1186/s12981-020-00284-1.
- 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.
Sirimon R Pratuangtham, MD contact
Somnuek Sungkanuparph, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Abnormal Glucose Metabolism, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somnuek Sungkanuparph, MD (+6622011581, somnuek.sun@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
new diabetes (time frame: 12 months after intervention). 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 NCT03545217, which also lists 2 linked publications.
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 4 Jun 2018.