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Protocol Details

2-5 Intermittent Caloric Restriction for Weight Loss and insulin Resistance in HIV-Infected Adults with Features of the Metabolic Syndrome

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-I-0075

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 65

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Fasting

Recruitment Keyword(s)

None

Condition(s)

Human Immunodeficiency Virus;
Metabolic Syndrome

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Intermittent fasting
Other: Standard of Care

Supporting Site

National Institute of Allergy and Infectious Diseases

Background:

Weight gain can lead to obesity and diabetes even in people living with human immunodeficiency virus (HIV). Researchers want to see if the technique intermittent calorie restriction can help overweight people with HIV as an alternative to traditional diets.

Objective:

To see if intermittent calorie restriction leads to weight loss and improved blood sugar in obese people with HIV.

Eligibility:

Adults ages 18-65 with HIV who are obese and do not have diabetes

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests.

Before starting treatment, participants will:

-Have a nutritional consultation

-Get a pedometer to record daily steps

-Test a restricted diet for 1 day

-Have a body x-ray

At the baseline visit, participants will have:

-Blood drawn after they drink a sugar drink

-Questions about their health and eating

-A nutritional consultation

-Resting energy expenditure measured. Participants will fast overnight. Then they will lie down while a plastic bubble goes over the head and a plastic sheet covers the upper body. Oxygen flows into the bubble.

-Liver stiffness test. A wand on the stomach releases sound waves like an ultrasound.

For 12 weeks, some participants will be on a standard diet. Others will restrict how much food they eat 2 days a week. On those days they will eat about 25% of their recommended calories.

Participants will keep a diary of their diet and steps.

Participants will have 4 visits during the 12-week diet and 1 visit 12 weeks after the diet ends. They will repeat previous tests.

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Eligibility

INCLUSION CRITERIA:

1. Age 18 - 65 years

2. HIV RNA level less than or equal to 200 copies/mL for greater than or equal to1 year (1 measure greater than or equal to 200 allowed if also <500 and preceded and followed by one or more undetectable values)

3. CD4 > 200 cells/mL and no active opportunistic infection or malignancy

4. BMI greater than or equal to 30 kg/m^2

5. One or more components of the metabolic syndrome as defined below.

-Risk Factor: Waist circumference

--Men: Defining Level: > 102 cm

--Women: Defining Level: > 88 cm

-Risk Factor: Triglycerides, greater than or equal to 150 mg/dL

-Risk Factor: High density lipoprotein (HDL) cholesterol

--Men: Defining Level: < 40 mg/dL

--Women: Defining Level: < 50 mg/dL

-Risk Factor: Blood pressure, greater than or equal to 130 / greater than or equal to 85 mmHg

-Risk Factor: Fasting glucose, greater than or equal to 110 mg/dL

6. Fasting blood glucose > 60 mg/dL at screening

7. Willingness to allow sample storage for future research

EXCLUSION CRITERIA:

1. Established diagnosis of diabetes mellitus use of anti-diabetes medications, or a HgbA1C of >7.0 %

2. History of eating disorder, uncontrolled mood or thought disorder, significant gastrointestinal disorder or malabsorption, or significant hepatic or renal impairment

3. Current use of medical therapy for overweight/obesity including phentermine, orlistat, lorcaserin, naltrexone/bupropion, and liraglutide or history of weight loss surgery. Concomitant use of medications with side effects known to potentially influence appetite are allowed if on a stable dose for at least 12 months

4. History of symptomatic hypoglycemia.

5. Use of systemic glucocorticoids (stable dose daily inhaled corticosteroid allowed)

6. Chronic viral hepatitis C; subjects with a history of hepatitis C successfully treated can enroll >12 months after sustained virologic response

7. Alcohol or substance use disorder in the past year as defined by DSM-V or positive urine drug screen

8. Current pregnancy, actively seeking to become pregnant or breastfeeding

9. Any serious health or other condition which, in the opinion of the Principal Investigator or their designee, could potentially interfere with the ability of a subject to comply with the procedures and assessments of the protocol or to safely participate and complete the study


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Colleen M. Hadigan, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)



Cheryl L. Chairez
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 9N214
10 Center Drive
Bethesda, Maryland 20892
(301) 496-3840
chairezc@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03489109

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