Insulin Sensitivity Clinical Trial
— SupercompOfficial title:
Regulation of Glycogen Supercompensation in Human Skeletal Muscle
Verified date | March 2018 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nine healthy, moderately fit male volunteers participated in the study. The subjects gave
written informed consent after having been informed of any possible risk and discomfort
associated with the study. The study was approved by the regional ethics committee in Denmark
(Journal number: H-4-2013-071) and performed in accordance with the Declarations of Helsinki
II.
All subjects underwent 3 clinical investigations (day 1, day 2 and day 5) during a 5 day
glycogen supercompensation regime. The subjects were asked to refrain from physical activity
and to eat a controlled diet containing 60% carbohydrates (CHO) for 4 days prior to the
initial experiments.
Upon arrival at the laboratory on day 1, the subjects performed one-legged knee extensor
exercise for 1 hour at 80% of PWL interspersed by 5 min bouts at 90% of PWL. This was
followed by interval exercise until exhaustion containing 4 min bouts starting at 100% PWL
followed by 1 min at 50% of PWL. Upon cessation of exercise the subjects showered and rested
in the supine position for 4 hours. Then a 120 min hyperinsulinemic euglycemic clamp was
initiated by a bolus insulin injection (9.0 mU/kg, Actrapid, Novo Nordisk, Denmark) followed
by continuous insulin infusion (1.42 mU/kg/min insulin) reaching a level of plasma insulin
around 100 µU/mL (n=9). At least 2 hours before the insulin clamp, catheters were placed in
both femoral, one antecubital and one dorsal hand vein. A heat pad was placed around the
lower part of the arm and hand in order to "arterialize" blood drawn from the hand vein.
Substrate uptake/release across the legs was calculated by multiplying the arterial-venous
(AV) difference in blood substrate concentration by femoral arterial blood flow (measured by
ultrasound, Philips DICOM). Blood glucose levels were maintained at the euglycemic predefined
target by continuously adjusting the glucose infusion rate (GIR) (20% glucose solution;
Fresenius Kabi, Sweden). Concurrent measures of substrate AV differences and blood flow were
performed every 20 min. Muscle biopsies from m. vastus lateralis were obtained under local
anaesthesia (3-5 ml of Xylocaine, 20 mg/ml.) in the basal- and insulin-stimulated state (120
min) by use of needle biopsy technique. Muscle specimen were frozen within 20 sec in liquid
nitrogen and stored at -80°C for further analysis. A new incision was made for every biopsy
and spaced 4-5 cm apart.
This insulin clamp procedure in combination with basal and insulin stimulated muscle biopsies
was repeated in the rested state (without prior exercise) on day 2 and day 5. The subjects
arrived in the morning in the overnight fasted state at day 1, day 2 and day 5. During the 5
day supercompensation regime the subjects were provided a predefined isocaloric diet
containing 80% carbohydrates, 10% fat and 10% proteins. All food items were handle out to the
subjects and compliance of the diet regime was ensured by survey.
Status | Completed |
Enrollment | 9 |
Est. completion date | December 31, 2014 |
Est. primary completion date | December 31, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 25 Years to 30 Years |
Eligibility |
Inclusion Criteria: - male - BMI between BMI 20-25 kg/m2 - healthy and not using medication - not smoking - habitual physical activity level of 2 - 6 hours pr. week - no incidence of diabetes, cardiovascular disease or other metabolic diseases in close family Exclusion Criteria: - female - BMI below 20 and above 25 kg/m2 - using medication - smoking - habitual physical activity level below 2 h pr. week or above 6 hours pr. week - incidence of diabetes, cardiovascular disease or metabolic disease in close family |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Nutrition, Exercise and Sports | Copenhagen | Capital Region |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Insulin action in skeletal muscle | Insulin action in skeletal muscle was investigated during hyperinsulinemic euglycemic conditions by combining AV-difference with blood flow measurements. | 1 week |
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