Clinical trial NCT03545217: Abnormal Glucose Metabolism in HIV-infected Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Glucose Metabolism
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2018-06-04
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: new diabetes
timeFrame: 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Somnuek Sungkanuparph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.