Abnormal Glucose Metabolism in HIV-infected Patients

Abnormal Glucose Metabolism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03545217
• Other study ID #: ID066011
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2017
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: Mahidol University
• Contact: Somnuek Sungkanuparph, MD
• Phone: +6622011581
• Email: somnuek.sun[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Glucose Metabolism

Intervention

Behavioral:
• Lifestyle Intervention
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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	University of Illinois at Chicago

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new diabetes	occurrence of diabetes mellitus	12 months after intervention