EFFect Of exercise on insulin ResisTance
- Conditions
- Insulin resistance (pre-diabetes)Nutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN16418171
- Lead Sponsor
- Alere San Diego Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 30
1. Aged 18 to 75 years
2. Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment)
2.a. Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ¡Ü 125 mg/dL (6.0-6.9 mmol/L)
2.b. HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
2.c. 2-hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
3. No clinically significant adverse exercise response during the maximal graded exercise test
1. Weight loss diet program or weight change (>10%) within the past 6 months
2. Daily physical activity of >10,000 steps per day (as measured during the interval between visits 1 and 2)
3. Participates in deliberate structured exercise
4. Pregnant or intending to become pregnant
5. Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
6. Unwillingness to participate in all study procedures
7. Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
8. BMI greater than 40 kg/m2
9. Concurrent participation in another lifestyle modification trial
10. Diagnosis of diabetes based on any one of the following criteria:
10.a. Fasting plasma or whole blood glucose ¡Ý 126 mg/dL (7 mmol/L)
10.b. HbA1c of >6.5% (>47 mmol/mol)
10.c. 2-hour plasma glucose ¡Ý 200 mg/dL (11.1 mmol/L) during an OGTT
11. Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:
11.a. Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months
11.b. Current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications
11.c. Current use of beta blockers (beta-adrenergic blocking agents)
11.d. Current or previous use (within the past year) of the following medications: diabetes related medications or insulin; metformin; growth hormone; glucagon; dipeptidyl peptidase-4(DPP-4) inhibitors (saxagliptin, stigagliptin); glucagon-Like Peptide-1(GLP-1) mimetics (exenatide, liraglutide); sulfonylurea medication or other potential confounding medications
11.e. Medical conditon which predetermines insulin resistance (e.g. Marfan syndrome / severe Polycystic ovary syndrome (PCOS) / Cushing syndrome etc.).
11.f. Fasting triglycerides > 1000 mg/dL
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to determine whether exercise consistent with current recommendations, in terms of weekly intensity and duration, can have a positive effect on insulin resistance (IR) in subjects with IR as measured by the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR). For the primary outcome, pre-exercise or baseline IR will be contrasted with post-exercise IR measurements within each subject. Up to six pre-exercise or baseline measurements, and up to four post-exercise IR measurements per subject will be obtained. The pre-exercise blood draws are obtained prior to the first exercise session and the post-exercise blood draws are obtained in the morning after an exercise session the previous day.
- Secondary Outcome Measures
Name Time Method There are also research objectives in the study, including defining the day to day variability in measures of fasting IR and evaluating the effects of duration and/or intensity of exercise on changes in IR. These measures will be based on the pre- and post-exercise blood draws