Early Phase 1 Type 2 Diabetes Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People of any gender are eligible to participate.
- People with a body mass index (BMI) between 18.5 and 40, whose weight has been stable for the past 6 months.
- People aged 18 to 64 years old.
- People who have blood sugar levels in the pre-diabetes range, based on at least one of several standard tests — or people who have been consistently taking Metformin for at least 1 year to prevent pre-diabetes from becoming diabetes (confirm with trial site for exact test values).
- People who currently do less than 150 minutes of moderate or vigorous physical activity per week and sit for more than 6 hours per day, based on a standard self-reported questionnaire.
- People who take fewer than 6,500 steps per day on average, as measured by a pedometer over 5 days (including at least one weekend day).
- People who pass the medical, physical, blood, and urine screening checks required by the trial.
- People who drink fewer than 3 cups of caffeinated beverages per day.
- People willing to avoid any additional structured exercise beyond what the study prescribes.
- People willing to follow a controlled diet for 3 days before and during clinic visits at the research centre.
- People willing to avoid over-the-counter and prescription medications (except oral contraceptives) for 3 days before inpatient clinic visits.
- People willing to wear a Fitbit® activity monitor and upload their daily activity data throughout the entire study.
- People willing to follow the physical activity programme and be randomly assigned to one of two study groups.
- People willing to complete all study procedures.
Who may not be able to join:
- Women who are pregnant, breastfeeding, or post-menopausal.
- People whom the study doctor considers unsafe to participate.
- People with a history of a systemic, psychiatric, or neurological disease, or a history of drug or alcohol abuse.
- People with a history of heart disease, diabetes, uncontrolled high blood pressure, untreated thyroid problems, kidney or liver disease, abnormal cholesterol levels, or any other condition that affects weight or fat metabolism.
- People who test positive for HIV or hepatitis B or C.
- People who have taken medications affecting weight, triglycerides, energy intake or expenditure, or sleep in the past 3 months.
- People whose blood test results are found to be significantly abnormal by the study doctor.
- People who currently smoke or who smoked within the 3 months before screening.
- People who have donated more than 400 mL of blood within 90 days of the screening visit.
- People who have worked night shifts within 1 month before the study or who would do so during the study.
- People who do not complete the required trial screening days used to assess their willingness and ability to participate in the study activities.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Audrey Bergouignan, PhD, University of Colorado, Denver
Phone: 303.724.6821
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Glycemia
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.