ClinicalTrials.Veeva

Menu

Study of Clinical Response to Acute Metformin by Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS (SCRAMBLED EGGS)

Mass General Brigham logo

Mass General Brigham

Status

Active, not recruiting

Conditions

Metabolism
Genetics
Type 2 Diabetes

Treatments

Other: Mixed Meal Tolerance Test
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT02087826
2014P000255

Details and patient eligibility

About

The purpose of this research study is to examine whether specific genes (e.g. SLC16A11) affect how human beings respond to food and a medication that is commonly used to treat type 2 diabetes. The food the investigators will be studying is specially prepared to contain protein, carbohydrate, and fat. The drug the investigators are studying is metformin. The investigators hypothesize that physiological responses to the meal and to the medication will differ between carriers and non-carriers of genes associated with type 2 diabetes.

Enrollment

1,017 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult males or non-pregnant females
  • Age 18-79
  • Able and willing to give consent relevant to genetic investigation

Exclusion criteria

  • Women who are pregnant, nursing, or at risk of becoming pregnant
  • Currently taking any medications used for the treatment of diabetes
  • 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
  • Contraindications to safe use of metformin, including planned radiologic or angiographic study requiring contrast within one week of the study completion
  • Planned changes to any prescribed medications, specifically diuretics, during study enrollment
  • Participation in any other interventional study during the study duration
  • Conditions causing intestinal malabsorption, including celiac disease or a history of intestinal or gastric bypass surgery
  • Dietary restrictions that would prevent consumption of a MMTT
  • Objection or inability to take metformin

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,017 participants in 2 patient groups, including a placebo group

Carriers of the SLC16A11 risk allele
Active Comparator group
Description:
Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin
Treatment:
Drug: Metformin
Other: Mixed Meal Tolerance Test
Non-carriers of the SLC16A11 risk allele
Placebo Comparator group
Description:
Day 1: Mixed Meal Tolerance Test Day 3-7: 500mg metformin, twice daily Day 8: Mixed Meal Tolerance Test in presence of Metformin
Treatment:
Drug: Metformin
Other: Mixed Meal Tolerance Test

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems