- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545217
Abnormal Glucose Metabolism in HIV-infected Patients
May 22, 2018 updated by: Somnuek Sungkanuparph, Mahidol University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Somnuek Sungkanuparph, MD
- Phone Number: +6622011581
- Email: somnuek.sun@mahidol.ac.th
Study Contact Backup
- Name: Sirimon R Pratuangtham, MD
- Email: sreutrak10800@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10400
- Recruiting
- Faculty of Medicine Ramathibodi Hospital, Mahidol University
-
Contact:
- Piyamitr Sritara, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: intervention group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
new diabetes
Time Frame: 12 months after intervention
|
occurrence of diabetes mellitus
|
12 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Somnuek Sungkanuparph, MD, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Phuphuakrat 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2017
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
May 22, 2018
First Submitted That Met QC Criteria
May 22, 2018
First Posted (Actual)
June 4, 2018
Study Record Updates
Last Update Posted (Actual)
June 4, 2018
Last Update Submitted That Met QC Criteria
May 22, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- ID066011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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