ObesityNCT00445627
Effect of Short-Term Beta-Cell Rest in Adolescents and Young Adults With Type 2 Diabetes Mellitus
An observational study of Obesity and Overweight, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Obesity, Overweight, Diabetes Mellitus, Type 2
- What is being tested?
- Metformin, Insulin and Nutrition counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2007to not given
- 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner.
Who may be able to join
- Type 2 diabetes mellitus as defined by:
- Fasting blood glucose greater than or equal to 126 mg/dL OR postprandial blood sugar greater than or equal to 200 mg/dL (either during OGTT at NIH or as previously documented on outside medical record).
- Since subjects may already have been started on treatment with hypoglycemic agents at the time of enrollment, they may have blood glucose levels in the impaired glucose tolerance range (fasting glucose 100-125 mg/dL and postprandial 140-199 mg/dL). This is a sign of adequately controlled diabetes, rather than an incorrect diagnosis of diabetes. Therefore, prior documentation (on outside medical records) of blood glucose values documenting diabetes will be acceptable if the subject has impaired glucose tolerance rather than overt diabetes according to screening results at NIH.
- Absence of insulin autoantibodies (in insulin na(SqrRoot) ve patients only)
- Or
- Clinical diagnosis of type 1 diabetes mellitus (for Pilot Study only)
Show all 11Show fewer
- And
- Age 8-25 years at enrollment
- Two types of volunteers will be recruited:
- Overweight and obese volunteers who will be BMI matched with study enrollees who have T2DM during analyses
- Normal weight (BMI between 5th and 85th centiles for age) volunteers
Who cannot join
- Normal OGTT at NIH (fasting blood glucose < 100 mg/dL AND 2 hour blood glucose < 140 mg/dL)
- Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject(specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
- Positive urine pregnancy test
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
- NON-DIABETIC CONTROLS:
- Diabetes
Show all 11Show fewer
- Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject (specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
- Current use of drugs that alter glucose metabolism (e.g. metformin)
- Current use of prescription or non-prescription weight-loss drugs
- Positive urine pregnancy test
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Natural History of Type 2 Diabetes Mellitus in Children and Young Adults
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.
Read more
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.
Read the 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:
- To characterize hormonal, metabolic, and behavioral traits in patients with youth-onset type 2 diabetes. These will include:
- Assessment of Beta-cell function and insulin resistance
- Psychological, demographic, and socioeconomic assessments
- Assessment of the physiology and pathophysiology of incretins and other gut hormones
- Identification of early biomarkers of diabetes complications, especially cardiovascular disease
- Validation of new methods for studying glucose metabolism
- 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 overweight/obese 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.
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Obesity, Insulin, Metformin, Natural History, Overweight
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Insulin Resistance
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 Lean Controls | Cross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA Receives: Behavioral: Nutrition counseling; Behavioral: Exercise counseling | |
| Overweight Obese Controls | Cross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA Receives: Drug: Metformin; Behavioral: Nutrition counseling; Behavioral: Exercise counseling | |
| Type 1 Diabetes | Cross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA Receives: Drug: Insulin; Behavioral: Nutrition counseling; Behavioral: Exercise counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate phenotype of T2DM
Measurements will include indices of beta-cell function, body composition, cardiovascular disease risk factors, gut hormones, and psychological well-being. These data will be compared to findings in non-diabetic volunteers who are lean or overweight/obese
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study start18 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stephanie T Chung, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445627
- Sponsor's protocol ID
- 070115
- Other IDs
- 07-DK-0115
- Status last verified
- 27 Jan 2026
- First submitted
- 8 Mar 2007
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dabelea D, Hanson RL, Bennett PH, Roumain J, Knowler WC, Pettitt DJ. Increasing prevalence of Type II diabetes in American Indian children. Diabetologia. 1998 Aug;41(8):904-10. doi: 10.1007/s001250051006.
PubMed 9726592Fridlyand LE, Philipson LH. Does the glucose-dependent insulin secretion mechanism itself cause oxidative stress in pancreatic beta-cells? Diabetes. 2004 Aug;53(8):1942-8. doi: 10.2337/diabetes.53.8.1942.
PubMed 15277370Gungor N, Bacha F, Saad R, Janosky J, Arslanian S. Youth type 2 diabetes: insulin resistance, beta-cell failure, or both? Diabetes Care. 2005 Mar;28(3):638-44. doi: 10.2337/diacare.28.3.638.
PubMed 15735201
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Type 2 Diabetes Mellitus in Children and Young Adults
- ClinicalTrials.gov ID
- NCT00445627
- Acronym / sponsor ID
- 070115
- Conditions
- Obesity, Overweight, Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes, Obesity, Insulin, Metformin, Natural History, Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 18 Jun 2007 (actual)
- First posted
- 9 Mar 2007 (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 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.
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:
- To characterize hormonal, metabolic, and behavioral traits in patients with youth-onset type 2 diabetes. These will include:
- Assessment of Beta-cell function and insulin resistance
- Psychological, demographic, and socioeconomic assessments
- Assessment of the physiology and pathophysiology of incretins and other gut hormones
- Identification of early biomarkers of diabetes complications, especially cardiovascular disease
- Validation of new methods for studying glucose metabolism
- 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 overweight/obese 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Lean Controls | – | Behavioral: Nutrition counseling, Behavioral: Exercise counselingCross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA |
| Overweight Obese Controls | – | Drug: Metformin, Behavioral: Nutrition counseling, Behavioral: Exercise counselingCross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA |
| Type 1 Diabetes | – | Drug: Insulin, Behavioral: Nutrition counseling, Behavioral: Exercise counselingCross-sectional analyses of continuous variables (e.g. hormonal measurements, inflammatory markers, lipids, BMI, and body composition measurements) will be compared using ANOVA |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and young adults ages 8 to 25 years with type 2 diabetes will be studied in a cross-sectional and longitudinal manner.
Key inclusion criteria (11 listed)
- Type 2 diabetes mellitus as defined by:
- Or
- Clinical diagnosis of type 1 diabetes mellitus (for Pilot Study only)
- And
- Age 8-25 years at enrollment
Key exclusion criteria (11 listed)
- Normal OGTT at NIH (fasting blood glucose < 100 mg/dL AND 2 hour blood glucose < 140 mg/dL)
- Significant comorbidity that, in the opinion of the investigators, will increase risk to the subject(specific obesity-related comorbidities are explicitly permitted, including hypertension, hyperlipidemia, obstructive sleep apnea and non-alcoholic steatohepatitis)
- Positive urine pregnancy test
- Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to comply with study procedures
- Diabetes
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 |
|---|---|---|
| Metformin | Drug | Overweight Obese Controls |
| Insulin | Drug | Type 1 Diabetes |
| Nutrition counseling | Behavioural | Healthy Lean Controls, Overweight Obese Controls, Type 1 Diabetes |
| Exercise counseling | Behavioural | Healthy Lean Controls, Overweight Obese Controls, Type 1 Diabetes |
Primary outcome
evaluate phenotype of T2DM
Time frame: 20 months
Measurements will include indices of beta-cell function, body composition, cardiovascular disease risk factors, gut hormones, and psychological well-being. These data will be compared to findings in non-diabetic volunteers who are lean or overweight/obese
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 16 Oct 2026.
- Background: PubMed 9726592Dabelea D, Hanson RL, Bennett PH, Roumain J, Knowler WC, Pettitt DJ. Increasing prevalence of Type II diabetes in American Indian children. Diabetologia. 1998 Aug;41(8):904-10. doi: 10.1007/s001250051006.
- Background: PubMed 15277370Fridlyand LE, Philipson LH. Does the glucose-dependent insulin secretion mechanism itself cause oxidative stress in pancreatic beta-cells? Diabetes. 2004 Aug;53(8):1942-8. doi: 10.2337/diabetes.53.8.1942.
- Background: PubMed 15735201Gungor N, Bacha F, Saad R, Janosky J, Arslanian S. Youth type 2 diabetes: insulin resistance, beta-cell failure, or both? Diabetes Care. 2005 Mar;28(3):638-44. doi: 10.2337/diacare.28.3.638.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Stephanie T Chung, M.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 and Overweight, 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 11 inclusion and 11 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 16 Oct 2026. 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?
evaluate phenotype of T2DM (time frame: 20 months). 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 NCT00445627, which also lists 3 linked publications.
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 16 Oct 2026.