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New treatment option for Pre-diabetes
Official title Mechanisms of Fatigability With Diabetes
ClinicalTrials.gov ID: NCT04442451
What this study is testing
- What it's testing
- Pre-diabetes (Pre-D) is a precursor to type 2 diabetes (T2D) and characterized by increased exercise fatigability of lower limb muscles, that can impede exercise performance. The cause for the increased fatigability in people with Pre-D is not known.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85
You may be able to join if
- Men and women adults 30 years to 85 years or less
- Pre-diabetes [glycosylated hemoglobin (HbA1c) of 5.7-6.4% and fasting plasma glucose 100-125 mg/dL at the time of initial screening]
- Controls [normoglycemic with a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)]
- Type 2 Diabetes Mellitus [elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%]
You likely can't join if
- Signs or symptoms of neuropathy
- Medications associated with advanced stages of T2D including insulin
- Poor glycemic control (HbA1c\>10%)
- Peripheral edema
- Severe obesity (BMI, \>45kg m-2)
- Untreated hypothyroidism
See the full eligibility criteria
- Men and women adults 30 years to 85 years or less
- Pre-diabetes [glycosylated hemoglobin (HbA1c) of 5.7-6.4% and fasting plasma glucose 100-125 mg/dL at the time of initial screening]
- Controls [normoglycemic with a HbA1c level ≤5.6% and fasting blood glucose ≤ 99 mg/dL (5.5 mmol/L)]
- Type 2 Diabetes Mellitus [elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%]
- Signs or symptoms of neuropathy
- Medications associated with advanced stages of T2D including insulin
- Poor glycemic control (HbA1c\>10%)
- Peripheral edema
- Severe obesity (BMI, \>45kg m-2)
- Untreated hypothyroidism
- Smoking
- Hypertension
- Cardiovascular or musculoskeletal disease that preclude exercise testing
- Hormone replacement drugs or vasoactive medications
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.