Type 2 DiabetesNCT00361946
The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM).
An observational study of Type 2 Diabetes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal challenge. Specifically we will be measuring the following parameters of postprandial metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3. Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2010
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents age 12-18
Who may be able to join
- Group A- Lean Adolescents a. Inclusion criteria: This group will consist of 20 lean adolescents between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, have a BMI less than 85th and above 20th for age and an HbA1C less than or equal to 6% (normal range is 4-6%). They should not be taking any medications. A DXA scan will be performed to estimate lean and fat body mass. The body fat mass should be less than or equal to 25 % to be included in this group (in the lean range). The subjects will be matched for age and Tanner stage to the subjects in Group B and C. Menstruating females must have a negative urine pregnancy test for inclusion.The subject must weigh more than 43 kg.
- Group B- Obese Adolescents a. Inclusion criteria: This group will consist of obese adolescents, between the ages of 12-18 years and Tanner stage 3-5 for pubertal development. They must have: a BMI above or equal to 95th for age, but not greater than 40 kg/m2 . They must have a normal glucose tolerance, in other words subjects with undiagnosed impaired glucose tolerance or diabetes will not be considered for the study. To test them for diabetes or impaired glucose tolerance they will undergo a 2-hour Glucose tolerance test (2hr-GTT). The ADA criteria will be used for the diagnosis of diabetes and/or impaired glucose tolerance (fasting plasma glucose < 110 mg/dl and a 2 hour postprandial blood glucose < 140 mg/dl). They must have and normal liver function tests and not taking any medications. The subjects will undergo DXA scan for estimation of total lean and fat body mass. The fat mass should be more than or equal to 30% to be considered obese. The subjects in this group will be matched for age (plus minus 1year), Tanner stage (plus minus 1) and body fat mass (plus minus 5%) to the Type 2 diabetes adolescents?. Menstruating females must have a negative urine pregnancy test for inclusion. 3. Group C- T2DM Adolescents a. Inclusion criteria The study group will consist of adolescents with T2DM, between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, BMI above or equal to 85th for age (but less than 40 kg/m2) and HbA1c less than 8.5%. They must have T2DM diagnosed for at least 2years, treated with diet , oral hypoglycemic agents and or insulin. If on medications they need to be on a stable dose of insulin and / or oral hypoglycemic agent over the last 2 months. The subjects must be otherwise healthy except for hypothyroidism stable on treatment. Menstruating females must have a negative urine pregnancy test for inclusion. -
Who cannot join
- Group A- Lean Adolescents a. Exclusion criteria: The subjects will be excluded if they have: a history of chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc), allergy to local anesthetics (ELAMAX Cream), evidence or history of chemical abuse, anemia and elevated liver enzymes (AST above 80 U/L and ALT above 110 U/L).
- Group B- Obese Adolescents a. Exclusion criteria: The exclusion criteria are the same as for control group A.
- Study Group C- T2DM Adolescents a. Exclusion Criteria: The exclusion criteria will be the same as in the control groups with one addition, subjects may not have been admitted to the hospital for diabetic ketoacidosis in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal challenge. Specifically we will be measuring the following parameters of postprandial metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3. Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate
Read the detailed description
Previously type 2 diabetes mellitus (T2DM) was considered a disease of the adult; however, the incidence of T2DM in children is on the rise. Consequently, complications may occur at an earlier age, underscoring the importance of improving glycemic control in the pediatric population. Postprandial hyperglycemia contributes significantly to poor glycemic control in T2DM. We now understand that in addition to insulin other hormones (glucagon, amylin and GLP-1) may play a role in the postprandial glucose metabolism. The role of gastric emptying has been increasingly recognized as an important factor in regulating glucose appearance into the circulation. Abnormalities in the pancreatic hormone amylin and the incretin GLP-1 have emerged as contributors to the alterations in gastric emptying and postprandial hyperglycemia in T2DM. Although much is know about the abnormalities related to postprandial hyperglycemia in adults with T2DM, little information is available in the pediatric population. This protocol will examine gastric emptying, glucagon, GLP-1 and amylin secretions in healthy lean, obese children with and without diabetes post-ingestion of a mixed meal. The subject will be age and Tanner stage matched. The goal of this project is to better understand the metabolic adaptations of postprandial glucose homeostasis in T2DM by comparing our study group to obese (normal glucose tolerance) and healthy (lean) controls. The long-term goal for the PI is to use the data gathered with this protocol to develop a K-23 proposal incorporating new therapeutic options through the use of amylin and GLP-1 analogs in children with T2DM to improve postprandial hyperglycemia.
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Lean, Obese
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
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 |
|---|---|---|
| lean subjects | BMI <85th for age, normal glucose tolerance | |
| obese subjects | BMI> 95th for age normal glucose tolerance | |
| Type diabetes | BMI > 85th for age , history of Type 2 diabetes as per ADA criteria |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa M. Rodriguez, Baylor College of Medicine
- Investigators
- Luisa M Rodriguez, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361946
- Sponsor's protocol ID
- NIH 1K126K63691
- Other IDs
- H-17370
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2006
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Amylin and Incretins on Postprandial Metabolisms in Adolescents With Type 2 Diabetes Mellitus (T2DM).
- ClinicalTrials.gov ID
- NCT00361946
- Acronym / sponsor ID
- NIH 1K126K63691
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Lean, Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Aug 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.
To study postprandial metabolism in lean, obese and T2DM adolescents using a mixed meal challenge. Specifically we will be measuring the following parameters of postprandial metabolism: 1. Postprandial glucose and triglycerides excursions 2. Gastric emptying 3. Insulin, amylin, glucagon, GLP-1 and ghrelin secretion 4. Glucose Turnover rate
Detailed description
Previously type 2 diabetes mellitus (T2DM) was considered a disease of the adult; however, the incidence of T2DM in children is on the rise. Consequently, complications may occur at an earlier age, underscoring the importance of improving glycemic control in the pediatric population. Postprandial hyperglycemia contributes significantly to poor glycemic control in T2DM. We now understand that in addition to insulin other hormones (glucagon, amylin and GLP-1) may play a role in the postprandial glucose metabolism. The role of gastric emptying has been increasingly recognized as an important factor in regulating glucose appearance into the circulation. Abnormalities in the pancreatic hormone amylin and the incretin GLP-1 have emerged as contributors to the alterations in gastric emptying and postprandial hyperglycemia in T2DM. Although much is know about the abnormalities related to postprandial hyperglycemia in adults with T2DM, little information is available in the pediatric population. This protocol will examine gastric emptying, glucagon, GLP-1 and amylin secretions in healthy lean, obese children with and without diabetes post-ingestion of a mixed meal. The subject will be age and Tanner stage matched. The goal of this project is to better understand the metabolic adaptations of postprandial glucose homeostasis in T2DM by comparing our study group to obese (normal glucose tolerance) and healthy (lean) controls. The long-term goal for the PI is to use the data gathered with this protocol to develop a K-23 proposal incorporating new therapeutic options through the use of amylin and GLP-1 analogs in children with T2DM to improve postprandial hyperglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lean subjects | – | –BMI <85th for age, normal glucose tolerance |
| obese subjects | – | –BMI> 95th for age normal glucose tolerance |
| Type diabetes | – | –BMI > 85th for age , history of Type 2 diabetes as per ADA criteria |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents age 12-18
Key inclusion criteria (2 listed)
- Group A- Lean Adolescents a. Inclusion criteria: This group will consist of 20 lean adolescents between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, have a BMI less than 85th and above 20th for age and an HbA1C less than or equal to 6% (normal range is 4-6%). They should not be taking any medications. A DXA scan will be performed to estimate lean and fat body mass. The body fat mass should be less than or equal to 25 % to be included in this group (in the lean range). The subjects will be matched for age and Tanner stage to the subjects in Group B and C. Menstruating females must have a negative urine pregnancy test for inclusion.The subject must weigh more than 43 kg.
- Group B- Obese Adolescents a. Inclusion criteria: This group will consist of obese adolescents, between the ages of 12-18 years and Tanner stage 3-5 for pubertal development. They must have: a BMI above or equal to 95th for age, but not greater than 40 kg/m2 . They must have a normal glucose tolerance, in other words subjects with undiagnosed impaired glucose tolerance or diabetes will not be considered for the study. To test them for diabetes or impaired glucose tolerance they will undergo a 2-hour Glucose tolerance test (2hr-GTT). The ADA criteria will be used for the diagnosis of diabetes and/or impaired glucose tolerance (fasting plasma glucose < 110 mg/dl and a 2 hour postprandial blood glucose < 140 mg/dl). They must have and normal liver function tests and not taking any medications. The subjects will undergo DXA scan for estimation of total lean and fat body mass. The fat mass should be more than or equal to 30% to be considered obese. The subjects in this group will be matched for age (plus minus 1year), Tanner stage (plus minus 1) and body fat mass (plus minus 5%) to the Type 2 diabetes adolescents?. Menstruating females must have a negative urine pregnancy test for inclusion. 3. Group C- T2DM Adolescents a. Inclusion criteria The study group will consist of adolescents with T2DM, between the ages of 12-18 years, Tanner stage 3-5 for pubertal development, BMI above or equal to 85th for age (but less than 40 kg/m2) and HbA1c less than 8.5%. They must have T2DM diagnosed for at least 2years, treated with diet , oral hypoglycemic agents and or insulin. If on medications they need to be on a stable dose of insulin and / or oral hypoglycemic agent over the last 2 months. The subjects must be otherwise healthy except for hypothyroidism stable on treatment. Menstruating females must have a negative urine pregnancy test for inclusion. -
Key exclusion criteria (3 listed)
- Group A- Lean Adolescents a. Exclusion criteria: The subjects will be excluded if they have: a history of chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc), allergy to local anesthetics (ELAMAX Cream), evidence or history of chemical abuse, anemia and elevated liver enzymes (AST above 80 U/L and ALT above 110 U/L).
- Group B- Obese Adolescents a. Exclusion criteria: The exclusion criteria are the same as for control group A.
- Study Group C- T2DM Adolescents a. Exclusion Criteria: The exclusion criteria will be the same as in the control groups with one addition, subjects may not have been admitted to the hospital for diabetic ketoacidosis in the last 6 months.
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
Not reported in the source record.
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 24 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Luisa M Rodriguez, MD principal investigator
Baylor College of Medicine
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 Type 2 Diabetes, run by Baylor College of Medicine 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 2 inclusion and 3 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 24 Apr 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?
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.
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 24 Apr 2017.