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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted21 Jun 2006 (estimated)
- Study start4 Sep 2003
- Primary completion18 Sep 2018
- Study completion10 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Arthur Sherman, Ph.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Cell Size In Human Insulin Resistance
- ClinicalTrials.gov ID
- NCT00341406
- Acronym / sponsor ID
- 999903290
- Conditions
- Obesity
- Keywords
- Multisizer 3, Signaling, Obesity, Type 2 Diabetes, Adipose Cell Turn Over
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 4 Sep 2003 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adipose cell size distribution
Time frame: end of study
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Sherman, Ph.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
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.