Type I Diabetes MellitusNCT01467063
Glutamine and Insulin Sensitivity in Type I Diabetes
A study testing Glutamine in people with Type I Diabetes Mellitus, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Type I Diabetes Mellitus
- What is being tested?
- Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jul 2013
- Phase
- Interventional
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type I diabetes diagnosed for > 12 months.
- Minimal weight of 40 kg
- Tanner stage IV or beyond
- All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
- HbA1C between 7.5 and 10%
- BMI between 10th to 85th percentile
- Patients on stable thyroid replacement therapy will be allowed to participate.
Who cannot join
- Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
- Cystic Fibrosis
- Chronic steroid therapy
- Chronic medications that may interfere with glucose metabolism or liver function
- History of mental retardation
- Presence of diabetic complications
Show all 9Show fewer
- Positive pregnancy test
- Presence of significant anemia (Hb<11 g/dL)
- Presence of intercurrent infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
Official title: Dietary Amino Acids and Insulin Sensitivity in Children With Type 1 Diabetes
Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence.
The overall objective of this project is to gain further insight into the possible benefits of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely measured amounts of glucose by vein: the amount of glucose required to prevent a drop in blood sugar reflects the body's sensitivity to insulin. The investigators will also give an IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive isotopes to better understand how glutamine may work. This procedure will be performed in 2 groups of 10 adolescents in the morning either after a strenuous exercise performed the previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject will be studied twice, once after taking oral GLN, once after placebo, in separate clinical research center (CRC) admissions a few weeks apart, in random order.
Should the investigators hypothesis prove to be true, it would warrant long term studies to determine whether sustained dietary GLN supplementation can decrease insulin requirements and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach could potentially have a significant positive impact in terms of adolescent health.
- Conditions
- Type I Diabetes Mellitus
- Being tested
- Glutamine, Placebo
- Keywords
- Type I Diabetes, Insulin Resistance, Glutamine, Amino Acids, Glucagon like peptide 1, Glutathione, Citrulline, Arginine, Nitric Oxide
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
PlaceboDietary supplement
Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Active comparator | Not described Receives: Dietary Supplement: Glutamine |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
Measured: During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Secondary outcomes (1)
Glucagon-like Peptide 1 (GLP-1)
Measured: Post-Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJul 2013
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type I Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Dominique Darmaun, Nemours Children's Clinic
- Investigators
- Dominique Darmaun, MD, PhD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467063
- Sponsor's protocol ID
- IRC# 11-29
- Status last verified
- Jul 2021
- First submitted
- 2 Nov 2011
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mauras N, Xing D, Fox LA, Englert K, Darmaun D. Effects of glutamine on glycemic control during and after exercise in adolescents with type 1 diabetes: a pilot study. Diabetes Care. 2010 Sep;33(9):1951-3. doi: 10.2337/dc10-0275. Epub 2010 Jun 28.
PubMed 20585005Torres-Santiago L, Mauras N, Hossain J, Weltman AL, Darmaun D. Does oral glutamine improve insulin sensitivity in adolescents with type 1 diabetes? Nutrition. 2017 Feb;34:1-6. doi: 10.1016/j.nut.2016.09.003. Epub 2016 Sep 20.
PubMed 28063503
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Amino Acids and Insulin Sensitivity in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01467063
- Acronym / sponsor ID
- IRC# 11-29
- Conditions
- Type I Diabetes Mellitus
- Keywords
- Type I Diabetes, Insulin Resistance, Glutamine, Amino Acids, Glucagon like peptide 1, Glutathione, Citrulline, Arginine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulin is crucial to help the body metabolize ('burn') sugar (glucose). Even though juvenile (type 1) diabetes (T1D) is primarily due to the lack of insulin, patients with T1D tend to become less sensitive to insulin, particularly during adolescence.
The overall objective of this project is to gain further insight into the possible benefits of supplementation with glutamine (GLN), a natural dietary amino acid, enhancing insulin sensitivity in adolescents with T1D. To elucidate the impact of glutamine, the investigators will use a method called the 'euglycemic, hyperinsulinemic clamp': it consists of giving an IV drip of insulin, while the drop in blood sugar is prevented by giving variable, precisely measured amounts of glucose by vein: the amount of glucose required to prevent a drop in blood sugar reflects the body's sensitivity to insulin. The investigators will also give an IV drip of glucose and arginine (a building block of protein) 'tagged' with non-radioactive isotopes to better understand how glutamine may work. This procedure will be performed in 2 groups of 10 adolescents in the morning either after a strenuous exercise performed the previous afternoon (group 1; n=10), or after a sedentary day (group 2; n=10). Each subject will be studied twice, once after taking oral GLN, once after placebo, in separate clinical research center (CRC) admissions a few weeks apart, in random order.
Should the investigators hypothesis prove to be true, it would warrant long term studies to determine whether sustained dietary GLN supplementation can decrease insulin requirements and ultimately improve diabetes control in teenagers with T1DM, If successful, this approach could potentially have a significant positive impact in terms of adolescent health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Active comparator | Dietary Supplement: Glutamine |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Type I diabetes diagnosed for > 12 months.
- Minimal weight of 40 kg
- Tanner stage IV or beyond
- All insulin programs, including intermediate/short acting insulins, Lantus/Detemir and short acting insulin or insulin pump therapy.
- HbA1C between 7.5 and 10%
Key exclusion criteria (9 listed)
- Celiac disease (any patient with history of positive serology or consuming a gluten-free diet)
- Cystic Fibrosis
- Chronic steroid therapy
- Chronic medications that may interfere with glucose metabolism or liver function
- History of mental retardation
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 |
|---|---|---|
| GlutamineParticipants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home. | Dietary supplement | Glutamine |
| PlaceboParticipants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home. | Dietary supplement | Placebo |
Primary outcome
Insulin Sensitivity
Time frame: During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours
Insulin sensitivity as measured by hyperinsulinemic-euglycemic clamp. Insulin sensitivity was calculated by dividing the average glucose infusion rate (mL glucose infusion/kg body weight/min) by the average insulin concentration (uU/mL).
1 secondary outcome
Glucagon-like Peptide 1 (GLP-1)
Time frame: Post-Infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20585005Mauras N, Xing D, Fox LA, Englert K, Darmaun D. Effects of glutamine on glycemic control during and after exercise in adolescents with type 1 diabetes: a pilot study. Diabetes Care. 2010 Sep;33(9):1951-3. doi: 10.2337/dc10-0275. Epub 2010 Jun 28.
- Results publication: PubMed 28063503Torres-Santiago L, Mauras N, Hossain J, Weltman AL, Darmaun D. Does oral glutamine improve insulin sensitivity in adolescents with type 1 diabetes? Nutrition. 2017 Feb;34:1-6. doi: 10.1016/j.nut.2016.09.003. Epub 2016 Sep 20.
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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.
Dominique Darmaun, MD, PhD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine in people with Type I Diabetes Mellitus, run by Nemours Children's Clinic 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 7 inclusion and 9 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 14 Jul 2021. 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. Some participants in this study may receive a placebo. 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 29 Jan 2021). 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?
Insulin Sensitivity (time frame: During the Hyperinsulinemic-Euglycemic Clamp, an average of 3 hours). 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 NCT01467063, which also lists 2 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 14 Jul 2021.