DiabetesPhase 1NCT02351323
Novel Type 2 Diabetes Mellitus Preventive Therapies
A Phase 1 study testing Glutamine (Pharmacological doses) and Lifestyle change in people with Diabetes, run by Boston Medical Center at 1 site in United States.
Trial summary
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Glutamine (Pharmacological doses) and Lifestyle change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2014
- Phase
- Phase 1
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- BMI (k/m2) >= 95th percentile;
- Weight 150 - 400 pounds;
- Language: English or Spanish (The PI speaks both English and Spanish fluently).
Who cannot join
- History of T2DM;
- Prior or current drug treatmeant that would effect diabetes risk
- Use of prescription strength glucocorticoids within three months before screening,
- History of syndrome or medical disorder associated with significant obesity;
- Serum creatinine >1.2 mg/dL;
- Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >90 international units (IU)/L (= 3 X normal limits);
Show all 18Show fewer
- Total bilirubin >2.5 time the upper limit of normal;
- History of moderate to extreme physical activity, past or current pregnancy;
- 9 .Use of illegal/illicit drugs;
- 10. Unable to comply with the protocol;
- 11. Any other serious disease determined by the clinician as potential study risk for the patient.
- 12. Have kidney or liver disorders, or conditions resulting in ammonia accumulation
- 13. Take Lactulose
- 14. Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light
- 15. Have manic episodes (mental illness)
- 16. Take medications to prevent seizures
- 17. Take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, ADHD medications, antilipidemiants, or thyroid hormone
- 18. Participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss
Trial locations and contacts
1 site in 1 country.
About this study
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the emerging evidence that glutamine and leucine (building blocks of protein) may affect energy partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk has been further evaluated in one adult observational cohort study but data on leucine are lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce insulin resistance, a diabetes risk factor.
The primary specific aim of the research plan is to conduct a randomized, double-blind, placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history of T2DM. At the end of the grant period, we will have obtained preliminary data to plan pivotal clinical trials of glutamine coupled with or without lifestyle changes.
Read the detailed description
Because of recruitment difficulties the design was modified several times until April 2013 when we were able to increase recruitment. The following changes were made from initial to final study design:
- Study moved from Clinical and Translational Science Institute (CTSI) to clinical setting (Nutrition and Fitness for Life Clinic)
- Ages eligible expanded from 12-19 years old to 12-19.9 years old
- Ethnicity/Race expanded from Hispanic only to include all races/ethnicities
- Patients without a past family history of T2DM were made eligible
- Study period was shortened from 6 months to 12-14 weeks
- Number of required visits were reduced from 5 visits to 3 visits (all of which took place during regularly scheduled clinic appointments)
- Open labeled but still randomized
- Those in the Glutamine arm were provided lifestyles change intervention
- Glycosylated hemoglobin (A1C) used instead of fasting Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
- Non-fasting blood draw rather than a fasting blood draw was instituted
- Conditions
- Diabetes
- Being tested
- Glutamine (Pharmacological doses), Lifestyle change
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine (Pharmacological doses)Drug
Also called NutreStore
30 grams/day of glutamine for 12-14 months
Lifestyle changeBehavioural
Lifestyle change as recommended by Registered Dietitian
| Study group | Role | What they receive |
|---|---|---|
| Glutamine + Lifestyle change | Experimental | Glutamine 30 grams/day X 12-14 weeks, Lifestyle change Receives: Drug: Glutamine (Pharmacological doses); Behavioral: Lifestyle change |
| No glutamine + Lifestyle change | Placebo comparator | Lifestyle change Receives: Behavioral: Lifestyle change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 12-14 weeks
Secondary outcomes (1)
Change in A1C
Measured: 12-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Boston 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine M Lenders, MD, ScD, MS, Principal investigator, Physician Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351323
- Sponsor's protocol ID
- H-27812 (K23DK082732)
- Status last verified
- Jan 2015
- First submitted
- 17 Dec 2014
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Type 2 Diabetes Mellitus Preventive Therapies
- ClinicalTrials.gov ID
- NCT02351323
- Acronym / sponsor ID
- H-27812 (K23DK082732)
- Conditions
- Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Jan 2015 (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.
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative obscurity to become one of the most serious complications of obesity in Hispanic obese populations, especially among those with a family history of T2DM. Few therapies have demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the emerging evidence that glutamine and leucine (building blocks of protein) may affect energy partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk has been further evaluated in one adult observational cohort study but data on leucine are lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce insulin resistance, a diabetes risk factor.
The primary specific aim of the research plan is to conduct a randomized, double-blind, placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history of T2DM. At the end of the grant period, we will have obtained preliminary data to plan pivotal clinical trials of glutamine coupled with or without lifestyle changes.
Detailed description
Because of recruitment difficulties the design was modified several times until April 2013 when we were able to increase recruitment. The following changes were made from initial to final study design:
- Study moved from Clinical and Translational Science Institute (CTSI) to clinical setting (Nutrition and Fitness for Life Clinic)
- Ages eligible expanded from 12-19 years old to 12-19.9 years old
- Ethnicity/Race expanded from Hispanic only to include all races/ethnicities
- Patients without a past family history of T2DM were made eligible
- Study period was shortened from 6 months to 12-14 weeks
- Number of required visits were reduced from 5 visits to 3 visits (all of which took place during regularly scheduled clinic appointments)
- Open labeled but still randomized
- Those in the Glutamine arm were provided lifestyles change intervention
- Glycosylated hemoglobin (A1C) used instead of fasting Homeostatic Model Assessment-Insulin Resistance (HOMA-IR)
- Non-fasting blood draw rather than a fasting blood draw was instituted
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine + Lifestyle change | Experimental | Drug: Glutamine (Pharmacological doses), Behavioral: Lifestyle changeGlutamine 30 grams/day X 12-14 weeks, Lifestyle change |
| No glutamine + Lifestyle change | Placebo comparator | Behavioral: Lifestyle changeLifestyle change |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- BMI (k/m2) >= 95th percentile;
- Weight 150 - 400 pounds;
- Language: English or Spanish (The PI speaks both English and Spanish fluently).
Key exclusion criteria (18 listed)
- History of T2DM;
- Prior or current drug treatmeant that would effect diabetes risk
- Use of prescription strength glucocorticoids within three months before screening,
- History of syndrome or medical disorder associated with significant obesity;
- Serum creatinine >1.2 mg/dL;
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 |
|---|---|---|
| Glutamine (Pharmacological doses)Also: NutreStore30 grams/day of glutamine for 12-14 months | Drug | Glutamine + Lifestyle change |
| Lifestyle changeLifestyle change as recommended by Registered Dietitian | Behavioural | Glutamine + Lifestyle change, No glutamine + Lifestyle change |
Primary outcome
Weight gain
Time frame: 12-14 weeks
1 secondary outcome
Change in A1C
Time frame: 12-14 weeks
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 30 Jan 2015.
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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.
Carine M Lenders, MD, ScD, MS principal investigator
Physician Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glutamine (Pharmacological doses) and Lifestyle change in people with Diabetes, run by Boston 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 3 inclusion and 18 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 30 Jan 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight gain (time frame: 12-14 weeks). It is what the study was designed to measure, not a finding.
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 30 Jan 2015.