No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
30 – 85
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
80 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for adults with pre-diabetes or type 2 diabetes to participate in an exercise program. Participants will help researchers understand how blood flow affects exercise performance.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 30 and 85 years old.
I have pre-diabetes.
I have type 2 diabetes.
I have normal blood sugar levels.
You may not be able to join if
I have signs of nerve damage.
I take insulin for diabetes.
My blood sugar control is poor.
I have swelling in my legs.
I am severely overweight.
I have untreated thyroid problems.
I smoke.
I have heart or muscle diseases that prevent exercise.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatigu…
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. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatiguing contractions of the lower limb muscles in people with Pre-D are limited by vascular dysfunction at multiple levels along the vascular tree including the artery, arteriole, and/or capillary. This clinical trial involves a novel exercise training regime involving blood flow restriction to the exercising limb will be used as a probe to further understand the vascular mechanisms for increased fatigability in people with Pre-D and T2D. The long-term goal is to better understand what limits exercise and functional performance in people with diabetes to help develop targeted, more effective exercise programs.
Trial Locations
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Eligibility Criteria
Inclusion 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 (…
Inclusion 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 \[elevated glycosylated hemoglobin (HbA1c) \>6.5% and \<10%\]
Exclusion Criteria:
* 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
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