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NCT00341406 · ClinicalTrials.gov registry record
Fat Cell Size in Insulin Resistance
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 782
- Enrollment target
NCT00341406: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00341406 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 782 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00341406 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 782 participants
- Enrollment target
Study Summary
This study, conducted at Stanford University in Palo Alto, California, will examine how insulin metabolism and cardiovascular risk are altered in response to weight loss. Insulin is a natural hormone that causes cells to remove glucose (sugar) from the blood. People who are insulin-sensitive remove glucose efficiently. People who are insulin-resistant require more insulin to remove glucose from the blood. Adult volunteers will be recruited for this study through advertisements in local newspapers in communities around Stanford University. Participants will undergo the following tests and procedures: * Insulin sensitivity testing: Before beginning the study, participants will be tested for insulin sensitivity. For the test, two small catheters (plastic tubes) are placed into two veins - one for infusing glucose, insulin, and sandostatin (a drug that blocks insulin secretion from the pancreas), and one for drawing blood samples. The infusions are done over 3 hours. Blood samples are collected before, during, and at the end of the study to measure how well the cells remove glucose from the blood in response to insulin. * Research diet: Participants are assigned to a low-calorie diet tailored to the individual's metabolic rate. The diets contain either 40 or 60 percent of total calories as carbohydrates, 40 or 20 percent as fat, and the rest as protein. People with type 2 diabetes who are taking diabetes medicine with have a diet of 45 to 50 percent carbohydrates, 35 to 40 percent fat, and the rest protein. * Meal profile: Before beginning the diet and after 4 months on the diet, participants are tested for the effects of the various study diets on control of blood sugar and fats. On the day of each test, participants have a physical examination and provide a medical history. Then, a small catheter is placed in a vein. Blood samples are drawn before breakfast and then hourly for up to 8 hours. * Participants who are diabetic are randomly assigned to take one of three
Primary Outcome
to look at role of the to look at role of the fat cell in relation to obesity and insulin resistance, the role of anti-inflammatory helper cells in protecting against insulin resistance, look at effects of overfeeding on fat cells and insulin resistance, measure inflammatory markers (during and after weight loss), quantify production of fat cells, total triglycerides production, and breakdown of fat cells.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 782 participants |
| Start Date | 2003-09-04 |
| Est. Completion | 2020-08-10 |
What the finished NCT00341406 record still lists
NCT00341406 is an observational study that tracks outcomes without assigning an intervention. The registered 782 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00341406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00341406 about?
NCT00341406 is a clinical study titled "Fat Cell Size in Insulin Resistance". This study, conducted at Stanford University in Palo Alto, California, will examine how insulin metabolism and cardiovascular risk are altered in response to weight loss. Insulin is a natural hormone that causes cells to remove glucose (sugar) from the blood. People who are insulin-sensitive remove ...
What is the current status of trial NCT00341406?
This trial is currently completed. The enrollment target is 782 participants. The study started on 2003-09-04. Estimated completion is 2020-08-10.
Who is sponsoring clinical trial NCT00341406?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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