NCT02184832

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.6 years

First QC Date

July 3, 2014

Last Update Submit

March 14, 2016

Conditions

Metformin ResponseFasting GlucoseTryptophan ConcentrationMetformin ConcentrationDiet Tolerability

Outcome Measures

Primary Outcomes (1)

  • change in fasting glucose

    2 days

Secondary Outcomes (1)

  • change in tryptophan concentration

    2 days

Other Outcomes (1)

  • tolerability of dietary tryptophan alteration

    2 days

Study Arms (2)

Low tryptophan diet

EXPERIMENTAL

2 days of a low tryptophan diet

Drug: MetforminOther: Low tryptophan diet

High tryptophan diet

EXPERIMENTAL

2 days of a high tryptophan diet

Drug: MetforminOther: High tryptophan diet

Interventions

MetforminDRUG

2 doses of 500 mg metformin given approximately 12 hrs apart

High tryptophan dietLow tryptophan diet
Low tryptophan dietOTHER
Low tryptophan diet
High tryptophan dietOTHER
High tryptophan diet

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adult male or non-pregnant female volunteers (age 20-40)
  • able and willing to give consent

You may not qualify if:

  • 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)
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Geoffrey Walford, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Medicine

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 9, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

US(1)