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ObesityNCT00341406

Fat Cell Size in Insulin Resistance

An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
How many people
782 participants
Where
1 siteUnited States
Study dates
4 Sep 2003to 10 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institute of Diabetes and Digestive and Kidney Disorders (NIDDK), 9000

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Adipose Cell Size In Human 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 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.

Read more

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.

Conditions
Obesity
Keywords
Multisizer 3, Signaling, Obesity, Type 2 Diabetes, Adipose Cell Turn Over
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00341406
Study groupRoleWhat they receive
Healthy volunteershealthy, non-overweight or other medical conditions
Patients overweightThose who are generally healthy but overweight
Patients with health conditionsThose with diabetes and cardiovascular disease.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start4 Sep 2003
  3. Primary completion18 Sep 2018
  4. Study completion10 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
782 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00341406
Sponsor's protocol ID
999903290
Other IDs
03-DK-N290
Status last verified
Aug 2020
First submitted
19 Jun 2006
Last updated
17 Aug 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adipose cell size distribution (time frame: end of study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.

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