A Phase 2 interventional study of High carb then high fat breakfast and High fat then high carb breakfast in Nephrotic Syndrome, Lipodystrophy and Metabolic Syndrome, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Diagnostic
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:
Participants may opt to have a third visit. At this visit, the breakfast will be high in protein....
Study Description:
This is a single site, randomized cross-over study assessing the effects of different test meals of varying macronutrient composition on post-prandial lipid metabolism. Studies will be conducted in healthy individuals and in several patient populations including those with nephrotic syndrome (NS), lipodystrophy, and metabolic syndrome.
The study hypothesis is that the number, composition and kinetics of lipid-containing particles will differ in the post-prandial state:
Objectives:
Endpoints:
Common inclusion criteria (all groups):
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Healthy control specific inclusion criteria:
Metabolic syndrome specific inclusion criteria
Obesity defined as either
Elevated waist circumference as defined below:
Country/Ethnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):
Country/Ethnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:
Plus any 2 of the following
Elevated triglycerides defined as EITHER
Low HDL cholesterol, defined as EITHER
Elevated blood pressure defined as EITHER
Elevated glucose defined as EITHER
Lipodystrophy-specific inclusion criteria:
Nephrotic syndrome specific inclusion criteria
Nephrotic range proteinuria defined by ANY of the following:
EXCLUSION CRITERIA:
Common exclusion criteria (all groups):
An individual who meets any of the following criteria will be excluded from participation in this study:
In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin > 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.
Healthy
Other: High carb then high fat breakfast · Other: High fat then high carb breakfast
Lipodystrophy
Other: High carb then high fat breakfast · Other: High fat then high carb breakfast
Metabolic syndrome
Other: High carb then high fat breakfast · Other: High fat then high carb breakfast
Nephrotic syndrome
Other: High carb then high fat breakfast · Other: High fat then high carb breakfast
High carb then high fat breakfast
High fat then high carb breakfast
Determine the difference in postprandial triglycerides between meals of different macronutrient composition within each study cohort.
Difference in baseline adjusted AUC for TG for 8 hours after meals of different macronutrient composition.
Time frame: 8 hours
Determine differences in post-prandial triglycerides between different study populations.
Difference in AUC for TG for each meal test between study cohorts
Time frame: 8 hours
Plan to share: Yes — This study will collect data from subjects enrolled at the NIH Clinical Center to meet the primary and secondary endpoints as stated in the protocol. Demographic, laboratory results, clinical observations and imaging studies will be acquired from up to 100 participants.
Supporting information: Study protocol, Sap, Icf
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)