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NCT07313787
Effects of Meal Macronutrients on Postprandial Lipids
Conditions: Nephrotic Syndrome, Lipodystrophy, Metabolic Syndrome, Healthy Volunteer, Diabetes, Metabolic Associated Steatotic Liver Disease
Sex: All
Ages: 18 Years – 120 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
Background:
Abnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.
Objective:
To learn more about how different types of foods affect fat levels in the blood.
Eligibility:
People aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.
Design:
Participants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.
Participants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.
Participants will have other tests during their stays:
* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.
* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.
* A Fibroscan is a special type of ultrasound of the liver.
* A body surface scan uses lasers to measure the total area of the body.
* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.
Participants may opt to have a third visit. At this visit, the breakfast will be high in protein....
Eligibility Criteria
* INCLUSION CRITERIA:
Common inclusion criteria (all groups):
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Age \>= 18 years
2. Average alcohol intake in the past 6 months \< 3 drinks (approximately 30g) per day (male) or \< 2 drinks (approximately 20 g) per day (female)
Healthy control specific inclusion criteria:
1. In good general health with no known active medical conditions as evidenced by medical history
2. Fasting glucose \=80cm
* Country/Ethnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:
* Sex: Male - Waist circumference: \>=90cm
* Sex: Female - Waist circumference: \>=80cm
2\. Elevated triglycerides defined as EITHER
2a. Fasting triglycerides \>= 150 mg/dL at screening, OR
2b. Specific treatment for hypertriglyceridemia
3\. Low HDL cholesterol, defined as EITHER
3a. HDL \= 85 mm Hg at screening, OR
4c. Treatment of previously diagnosed hypertension
5\. Elevated glucose defined as EITHER
5a. HbA1c \>= 5.7% (at screening), OR
5b. Fasting serum glucose \>= 100 mg/dL (at screening), OR
5c. 2-hour post-load glucose levels \>= 140 mg/dL (by history), OR
5d. Prior diagnosis of type 2 diabetes
Lipodystrophy-specific inclusion criteria:
1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at aminimum, the gluteofemoral depot).
2. Insulin resistance as defined by fasting insulin \>22.5 or high exogenous insulin requirement (\> 2 units per kg per day or \> 200 units total per day) at screening.
Nephrotic syndrome specific inclusion criteria
1. History of biopsy proven non-diabetic glomerular disease (any histology)
2. Nephrotic range proteinuria defined by ANY of the following:
2a. Protein/creatinine ratio uPCR \>= 3.5 g/g at screening, OR
2b. 24 hour protein excretion \>= 3.5 gr/24hr) at screening, OR
2c. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \5% or \>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.
4. Body weight \>450 lbs (upper limit that can be accommodated by DXA scanner).
5. Participating in a regular strenuous exercise program (\> 2h/week of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.
6. Uncontrolled diabetes, defined as HbA1c \>9% at screening.
7. Lipemia defined as fasting or non-fasting triglycerides of \>1000 mg/dL at screening.
8. Renal dysfunction defined as eGFR \ 0.5 g/dL, PT \> 18 seconds, albumin \< 3 g/dL, MELD score \> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial
peritonitis or liver transplant.
10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.
11. Positive pregnancy test or breastfeeding at screening.
12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.
13. Acute cardiovascular events within the past 6 months
14. Anemia (Hgb \
Source: ClinicalTrials.gov (NCT07313787). StuddyBuddy aggregates publicly available trial information.
