Metformin ResponseEarly Phase 1NCT02184832
Dietary Intake of Tryptophan and Metformin Response
A Early Phase 1 study testing Metformin, Low tryptophan diet and High tryptophan diet in people with Metformin Response and Fasting Glucose, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metformin Response, Fasting Glucose, Tryptophan Concentration
- What is being tested?
- Metformin, Low tryptophan diet and High tryptophan diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Mar 2016
- Phase
- Early 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy adult male or non-pregnant female volunteers (age 20-40)
- able and willing to give consent
Who cannot join
- Age less than 20 or greater than 40
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Body mass index (BMI) less than 20 or greater than 28
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
- Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study
- Known diabetes or pre-diabetes (based on prior diagnoses, use of medications to lower glucose; or fasting blood glucose > 100mg/dL at screening)
Show all 19Show fewer
- Untreated hypertension (defined as systolic blood pressure > 140mmHg and diastolic blood pressure > 90mmHg)
- Current or past mood disorder, including major depression, anxiety, or bipolar disorder
- Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
- History of liver disease and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 times upper limit of normal (ULN)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation
- Currently taking or intending to take during the study duration any medication known to affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones
- Use of medications and herbal or vitamin supplements during the study
- Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
- Objection to taking metformin
- Participation in any other interventional study during the study duration
- Use of nicotine-containing products, including inhaled, chewed, or patches during the study.
- Use of drugs of abuse.
- Restrictions that prevent adherence to standardized meals or unwillingness to adhere to a pre-specified meal plan, including abstinence from alcohol and limitation of caffeine intake to one drink daily.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study will examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.
- Conditions
- Metformin Response, Fasting Glucose, Tryptophan Concentration, Metformin Concentration, Diet Tolerability
- Being tested
- Metformin, Low tryptophan diet, High tryptophan diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
2 doses of 500 mg metformin given approximately 12 hrs apart
Low tryptophan dietOther
High tryptophan dietOther
| Study group | Role | What they receive |
|---|---|---|
| Low tryptophan diet | Experimental | 2 days of a low tryptophan diet Receives: Drug: Metformin; Other: Low tryptophan diet |
| High tryptophan diet | Experimental | 2 days of a high tryptophan diet Receives: Drug: Metformin; Other: High tryptophan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fasting glucose
Measured: 2 days
Secondary outcomes (1)
change in tryptophan concentration
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metformin ResponseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Walford, MD, Massachusetts General Hospital
- Investigators
- Geoffrey Walford, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184832
- Sponsor's protocol ID
- 2014P001226
- Status last verified
- Mar 2016
- First submitted
- 3 Jul 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake of Tryptophan and Metformin Response
- ClinicalTrials.gov ID
- NCT02184832
- Acronym / sponsor ID
- 2014P001226
- Conditions
- Metformin Response, Fasting Glucose, Tryptophan Concentration, Metformin Concentration, Diet Tolerability
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Jul 2014 (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 examine the influence of dietary intake of tryptophan on response to metformin. The investigators hypothesize that dietary tryptophan alteration will influence metformin response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low tryptophan diet | Experimental | Drug: Metformin, Other: Low tryptophan diet2 days of a low tryptophan diet |
| High tryptophan diet | Experimental | Drug: Metformin, Other: High tryptophan diet2 days of a high tryptophan diet |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy adult male or non-pregnant female volunteers (age 20-40)
- able and willing to give consent
Key exclusion criteria (19 listed)
- Age less than 20 or greater than 40
- Women who are pregnant, nursing, or at risk of becoming pregnant
- Body mass index (BMI) less than 20 or greater than 28
- Changes of more than 5 pounds in weight (increase or decrease) during the month prior to enrollment in the study
- Participation in more than 300 minutes of exercise per week during the month prior to enrollment in the study
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 |
|---|---|---|
| Metformin2 doses of 500 mg metformin given approximately 12 hrs apart | Drug | High tryptophan diet, Low tryptophan diet |
| Low tryptophan diet | Other | Low tryptophan diet |
| High tryptophan diet | Other | High tryptophan diet |
Primary outcome
change in fasting glucose
Time frame: 2 days
1 secondary outcome
change in tryptophan concentration
Time frame: 2 days
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 Mar 2016.
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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.
Geoffrey Walford, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin, Low tryptophan diet and High tryptophan diet in people with Metformin Response and Fasting Glucose, run by Massachusetts General Hospital 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 19 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 Mar 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
change in fasting glucose (time frame: 2 days). 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 16 Mar 2016.