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CompletedNCT00341406Updated Aug 17, 2020

Fat Cell Size in Insulin Resistance

An observational study in Obesity, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-08-17.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
782
Ages
18 Years to 65 Years
Sex
All
01

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 diabetes medications - rosiglitazone, glucophage, or a sulfonylurea compound - to help control blood glucose levels.
  • Magnetic resonance imaging: This diagnostic test uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the participant lies on a table in a narrow cylinder containing a magnetic field, wearing ear plugs to muffle loud knocking and thumping sounds that occur during the scanning process. He or she can speak with a staff member via an intercom system at all times during the procedure.

In addition to these procedures, patients may be asked to have a fat cell biopsy. This is done to determine whether insulin-resistant people have fewer fat cells but more fat per cell than insulin-sensitive people. For this test, a small piece of fat tissue is surgically removed, under local anesthetic, from an area of the lower abdomen. With the participant's consent, genetic testing may be done on the fat tissue sample to look for genes that may link central obesity to insulin resistance.

Some participants may be asked to be followed for an additional 3 months after completion of the study for a continued weight loss program. The follow-up includes weekly visits for weight measurements and a review of food records.

Read the detailed description

Little is known about the turnover of adipose cells in the fat depots of normal animals and human subjects. However, microarray analysis of adipose cell gene expression in high risk insulin-resistant human subjects suggests that a reduced rate of adipose cell turnover is associated with enhanced adipose cell size and systemic insulin resistance. New technology now permits a detailed analysis of adipose cell size including the detection of smaller cells which may be in the process of active differentiation. We propose to examine the relationship between adipose cell size distribution and systemic insulin resistance in obese human subjects. Adipose tissue biopsies will be obtained at Stanford University under protocols and consent forms approved by the Stanford University IRB. Only procedures already being performed on subjects under these protocols will be used.

02

Conditions studied

  • Obesity

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Keywords

  • Multisizer 3
  • Signaling
  • Obesity
  • Type 2 Diabetes
  • Adipose Cell Turn Over
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 782 is above the median of 80 across 339 observational studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The NIH is involved with several Stanford protocols that have recruited both males \& females between ages of 40-65 years of age who are either overweight patients but generally healthy, those with diabetes and cardiovascular medical conditions and/or are healthy volunteers.

Eligibility criteria

  • INCLUSION AND EXCLUSION CRITERIA:

Without regard to gender, race, or socioeconomic status, all subjects will be adult men and women. The racial/ethnic composition of the study population will be reflective of the communities surrounding Stanford University. Subjects will be recruited through placement of advertisements in local newspapers, but no subjects will be seen at NIH.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
782 participants (actual)

Groups and cohorts

  • Healthy volunteers

    healthy, non-overweight or other medical conditions

  • Patients overweight

    Those who are generally healthy but overweight

  • Patients with health conditions

    Those with diabetes and cardiovascular disease.

06

What researchers measure

Primary outcomes

  1. adipose cell size distribution

    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.

    Time frame: end of study

07

Study locations

1 site
  • National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), 9000
    Bethesda, Maryland 20892, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00341406
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Jun 21, 2006
Start date
Sep 4, 2003
Primary completion
Sep 18, 2018
Completion
Aug 10, 2020
Last update
Aug 17, 2020

Study contacts

Arthur Sherman, Ph.D.
principal investigator · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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