Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445627
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2007-03-08
Brief Title:
Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Natural History of Type 2 Diabetes Mellitus in Children and Young Adults
Status:
COMPLETED
Status Verified Date:
2024-04-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether resting beta cells cells in the pancreas that produce insulin for 2 weeks will improve the ability of patients with Type 2 diabetes mellitus T2DM to make insulin Beta cells can rest by giving patients insulin shots The study will also examine how teenagers with T2DM feel about having diabetes and explore differences between young people with and without T2DM
This study includes patients 12 to 25 years of age with T2DM who are overweight and who were diagnosed within 2 years of enrolling in the study Healthy individuals of normal weight or who are overweight are also eligible Candidates are screened with a medical history physical examination and laboratory tests
Participants with T2DM are assigned to one of two groups Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks Group 2 takes metformin follows the prescribed diet and receives insulin through a pump under the skin for 2 weeks During these two weeks all participants have the following tests
Frequent blood sugar checks
Oral glucose tolerance test routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution
Arginine stimulation to test the response of the body to arginine a normal ingredient of food that stimulates the release of insulin Two catheters are placed into veins in the arms one to administer a liquid containing arginine the other to draw the blood samples
Ultrasound of the blood vessels in the neck to check for hardening of the arteries
Metabolism test to measure the amount of oxygen used during rest The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes
MRI scans of the abdomen to examine the amount of fat in the belly at the beginning and end of the study
DEXA scan to determine percent body fat
Tests to explore quality of life and feelings about health work or school friends and family
Exercise testing on a treadmill or stationary bicycle
Genetic studies for information on diabetes and obesity
Normal volunteers have blood draws oral glucose tolerance testing MRI scan DEXA scan psychological testing exercise testing and genetic testing
This study includes patients 12 to 25 years of age with T2DM who are overweight and who were diagnosed within 2 years of enrolling in the study Healthy individuals of normal weight or who are overweight are also eligible Candidates are screened with a medical history physical examination and laboratory tests
Participants with T2DM are assigned to one of two groups Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks Group 2 takes metformin follows the prescribed diet and receives insulin through a pump under the skin for 2 weeks During these two weeks all participants have the following tests
Frequent blood sugar checks
Oral glucose tolerance test routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution
Arginine stimulation to test the response of the body to arginine a normal ingredient of food that stimulates the release of insulin Two catheters are placed into veins in the arms one to administer a liquid containing arginine the other to draw the blood samples
Ultrasound of the blood vessels in the neck to check for hardening of the arteries
Metabolism test to measure the amount of oxygen used during rest The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes
MRI scans of the abdomen to examine the amount of fat in the belly at the beginning and end of the study
DEXA scan to determine percent body fat
Tests to explore quality of life and feelings about health work or school friends and family
Exercise testing on a treadmill or stationary bicycle
Genetic studies for information on diabetes and obesity
Normal volunteers have blood draws oral glucose tolerance testing MRI scan DEXA scan psychological testing exercise testing and genetic testing
Detailed Description:
Background
Type 2 diabetes mellitus T2DM is a condition characterized by insulin resistance and progressive failure of the insulin-secreting beta-cells Previously considered a disease of adults it is now becoming increasingly prevalent in children and adolescents Patients with childhood onset T2DM are at very high risk for diabetes-related morbidity and mortality due to a longer life-time duration of diabetes as well as possible increased rapidity of Beta-cell failure
Aims
In this study we will address the following aims
1 To characterize hormonal metabolic and behavioral traits in patients with youth-onset type 2 diabetes These will include
1 Assessment of Beta-cell function and insulin resistance
2 Psychological demographic and socioeconomic assessments
3 Assessment of the physiology and pathophysiology of incretins and other gut hormones
4 Identification of early biomarkers of diabetes complications especially cardiovascular disease
5 Validation of new methods for studying glucose metabolism
2 To serve as a recruitment and development tool for hypothesis-driven pilot studies discussed in the appendices of this protocol
Methods
Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner Two control groups without diabetes will be studied for comparison purposes healthy lean controls and overweightobese controls Methods used to study participants include routine blood sampling oral glucose tolerance testing mixed meal testing arginine stimulation testing DEXA MRI carotid ultrasound questionnaires exercise physiology and measurements of energy expenditure Patients with type 1 diabetes will be studied using oral glucose tolerance and mixed meal tests in a pilot study of artificial sweeteners
Type 2 diabetes mellitus T2DM is a condition characterized by insulin resistance and progressive failure of the insulin-secreting beta-cells Previously considered a disease of adults it is now becoming increasingly prevalent in children and adolescents Patients with childhood onset T2DM are at very high risk for diabetes-related morbidity and mortality due to a longer life-time duration of diabetes as well as possible increased rapidity of Beta-cell failure
Aims
In this study we will address the following aims
1 To characterize hormonal metabolic and behavioral traits in patients with youth-onset type 2 diabetes These will include
1 Assessment of Beta-cell function and insulin resistance
2 Psychological demographic and socioeconomic assessments
3 Assessment of the physiology and pathophysiology of incretins and other gut hormones
4 Identification of early biomarkers of diabetes complications especially cardiovascular disease
5 Validation of new methods for studying glucose metabolism
2 To serve as a recruitment and development tool for hypothesis-driven pilot studies discussed in the appendices of this protocol
Methods
Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner Two control groups without diabetes will be studied for comparison purposes healthy lean controls and overweightobese controls Methods used to study participants include routine blood sampling oral glucose tolerance testing mixed meal testing arginine stimulation testing DEXA MRI carotid ultrasound questionnaires exercise physiology and measurements of energy expenditure Patients with type 1 diabetes will be studied using oral glucose tolerance and mixed meal tests in a pilot study of artificial sweeteners
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-DK-0115 | None | None | None |