ObesityNCT00602953

Role of Pancreatic Triglyceride Content in Beta-cell Function

An observational study of Obesity and Type 2 Diabetes, run by University of Texas Southwestern Medical Center 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

The study evaluates if fat accumulates in the pancreas in individuals at risk of developing obesity-related diabetes. It also evaluates if the amount of fat in the pancreas can predict the residual functional capacity of the pancreas (insulin secretion). Read more about this study

Who is it for?: Ages 21 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Obesity, Type 2 Diabetes
How many people: 101 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Aug 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.

Who may be able to join

adults without prior history of pancreatic disease (other than diabetes)

Who cannot join

use of unapproved medications
contraindications to the MRI procedure
contraindications to frequent blood draws
pregnancy
use of more than 2 alcoholic drinks/day

Trial locations and contacts

1 site in 1 country.

United States1 site

UT Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

Conditions: Obesity, Type 2 Diabetes
Being tested: No intervention planned.
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.

No intervention planned.Other
This is a cross-sectional observational study, no intervention is planned.

Study groups in NCT00602953
Study group	Role	What they receive
Healthy volunteers		Normal weight and normal glucose tolerance. Receives: Other: No intervention planned.
Pre-diabetes		Impaired fasting glucose of impaired glucose tolerance. Receives: Other: No intervention planned.
Overweight		Overweight or obese volunteers, but with normal fasting and postprandial glucose levels. Receives: Other: No intervention planned.
Type 2 diabetes		Patients with type 2 diabetes. Receives: Other: No intervention planned.
Type 1 diabetes		Patients with type 1 diabetes. Receives: Other: No intervention planned.

What is being measured

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

Pancreatic and Liver Fat
Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Measured: Within 1 month after screening visit.
Beta-cell Function; AIRg - Acute Insulin Response to Glucose
Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).
AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected.
Measured: At screening visit.
Insulin Sensitivity (SI)
Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI).
Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin.
Measured: At screening visit.
Disposition Index (DI)
Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function.
Measured: At screening visit.

Timeline

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

Sep 2007Aug 2012

First posted28 Jan 2008 (estimated)
Study startSep 2007
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe 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: Other
Time perspective: Cross-sectional
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00602953
Sponsor's protocol ID: 042007-021
Other IDs: 1K23RR02447001
Status last verified: Nov 2017
First submitted: 25 Oct 2007
Last updated: 26 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Pancreatic Triglyceride Content in Beta-cell Function
ClinicalTrials.gov ID: NCT00602953
Acronym / sponsor ID: 042007-021
Conditions: Obesity, Type 2 Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Sep 2007
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 26 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 5

Arm	Type	Receives
Healthy volunteers	–	Other: No intervention planned.Normal weight and normal glucose tolerance.
Pre-diabetes	–	Other: No intervention planned.Impaired fasting glucose of impaired glucose tolerance.
Overweight	–	Other: No intervention planned.Overweight or obese volunteers, but with normal fasting and postprandial glucose levels.
Type 2 diabetes	–	Other: No intervention planned.Patients with type 2 diabetes.
Type 1 diabetes	–	Other: No intervention planned.Patients with type 1 diabetes.

Who may qualify

Ages: 21 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: We enroll adult volunteers of all ethnicities who have no contraindications to the study procedures or use medications that interfere with our measurements.

Key inclusion criteria (1 listed)

adults without prior history of pancreatic disease (other than diabetes)

Key exclusion criteria (5 listed)

use of unapproved medications
contraindications to the MRI procedure
contraindications to frequent blood draws
pregnancy
use of more than 2 alcoholic drinks/day

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No intervention planned.This is a cross-sectional observational study, no intervention is planned.	Other	Healthy volunteers, Overweight, Pre-diabetes, Type 1 diabetes, Type 2 diabetes

Primary outcome

Pancreatic and Liver Fat
Time frame: Within 1 month after screening visit.
Pancreatic and liver triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).
Beta-cell Function; AIRg - Acute Insulin Response to Glucose
Time frame: At screening visit.
Beta-cell function as measured by frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). AIRg - acute insulin response to glucose. Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected.
Insulin Sensitivity (SI)
Time frame: At screening visit.
Sensitivity index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Higher numbers indicates better insulin sensitivity Insulin sensitivity was estimated as Matsuda index using formula = 10,000 / (FPG x FPI x Glucosemean0-180 x Insulinmean0-180)0.5, where FPG = fasting plasma glucose and FPI = fasting plasma insulin.
Disposition Index (DI)
Time frame: At screening visit.
Disposition index measured during frequently sampled intravenous glucose tolerance test (FSIVGTT) in volunteers with a wide range of body mass index (BMI). Blood samples were collected at -5, -1, 2, 3, 4, 5, 6, 8, 10, 14, 19, 22, 25, 30, 40, 50, 70, 100, 140, and 180 minutes, where time 0 is when an i.v. bolus of 50% glucose solution (0.3 g/kg) was injected. Disposition index (DI) was used to characterize the correlation between β-cell sensitivity and insulin sensitivity and was determined using formula DI = AIRg x SI (from outcomes 2 and 3). Higher numbers indicates a better improvement in beta-cell function.

Results and safety

Results posted to the registry on 26 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Volunteers	15	15
Pre-diabetes	26	26
Overweight	47	47
Type 2 Diabetes	13	13
Type 1 Diabetes	0	0

Primary outcome: Pancreatic and Liver Fat

Time frame: Within 1 month after screening visit.. Median (Inter-Quartile Range). Unit: percent

Measure	Healthy Volunteers n = 15	Pre-diabetes n = 26	Overweight n = 47	Type 2 Diabetes n = 13	Type 1 Diabetes n = 0
Pancreatic fat MRS	1.87 (0.2 to 6.26)	6.57 (1.90 to 17.93)	3.61 (0.79 to 8.98)	5.85 (3.43 to 13.96)	–
Liver fat MRS	0.96 (0.61 to 1.83)	4.09 (1.86 to 12.43)	3.33 (1.29 to 6.99)	8.76 (4.93 to 21.18)	–

Primary outcome: Beta-cell Function; AIRg - Acute Insulin Response to Glucose

Time frame: At screening visit.. Median (Inter-Quartile Range). Unit: microU/mL x min

Measure	Healthy Volunteers n = 15	Pre-diabetes n = 26	Overweight n = 47	Type 2 Diabetes n = 13	Type 1 Diabetes n = 0
Value	197.55 (118.15 to 237.42)	321.09 (151.71 to 446.46)	519.33 (385.59 to 927.69)	8.9 (1.0 to 56.58)	–

Primary outcome: Insulin Sensitivity (SI)

Time frame: At screening visit.. Median (Inter-Quartile Range). Unit: min-1 per pU/mL x 10v4

Measure	Healthy Volunteers n = 15	Pre-diabetes n = 26	Overweight n = 47	Type 2 Diabetes n = 13	Type 1 Diabetes n = 0
Value	5.48 (3.85 to 7.46)	2.28 (1.6 to 4.55)	2.29 (1.54 to 2.84)	1.55 (1.28 to 3.76)	–

Primary outcome: Disposition Index (DI)

Time frame: At screening visit.. Median (Inter-Quartile Range). Unit: Number

Measure	Healthy Volunteers n = 15	Pre-diabetes n = 26	Overweight n = 47	Type 2 Diabetes n = 13	Type 1 Diabetes n = 0
Value	1001.8 (744.52 to 1332.1)	739.84 (478.15 to 1026.53)	1031.26 (749.6 to 1796.35)	15.61 (4.31 to 133.19)	–

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Pre-diabetes	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Overweight	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Type 2 Diabetes	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Type 1 Diabetes	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ildiko Lingvay, MD, MPH, MSCS principal investigator

University of Texas Southwestern Medical Center

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 and Type 2 Diabetes, run by University of Texas Southwestern Medical Center 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 5 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 26 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pancreatic and Liver Fat (time frame: Within 1 month after screening visit.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00602953.

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 26 Dec 2017.