Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03458741
Study type Interventional
Source University of Copenhagen
Contact
Status Completed
Phase N/A
Start date September 5, 2013
Completion date December 31, 2014

See also
  Status Clinical Trial Phase
Recruiting NCT06042517 - Mechanisms of Ultrasound Neuromodulation Effects in Diabetes N/A
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03689738 - Effects of Potato Resistant Starch Intake on Insulin Sensitivity, Related Metabolic Markers and Satiety N/A
Recruiting NCT04195165 - The Effect of Sitting and Moderate Exercise on Plasma Insulin and Glucose Responses to an Oral Glucose Tolerance Test N/A
Recruiting NCT05441982 - Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes N/A
Terminated NCT03325933 - Resistance Training and Cardiometabolic Health N/A
Recruiting NCT05791968 - Blood Donation Could Improve Insulin Sensitivity N/A
Suspended NCT03240978 - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese N/A
Completed NCT02700698 - Mitochondrial Function in Circulating Cells and Muscle Tissue
Completed NCT02913079 - The Acute Impact of Sit-stand Desks on Post-meal Blood Sugar Levels N/A
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Completed NCT02058914 - Effects of Sugar Sweetened Beverage on Metabolic Health in Male and Female Adolescents N/A
Enrolling by invitation NCT02192684 - Obesity, Sleep Apnea, and Insulin Resistance N/A
Completed NCT00936130 - Bariatric Surgery and Weight Loss on Energy Metabolism and Insulin Sensitivity N/A
Completed NCT01216956 - Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia N/A
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT04168372 - Fructose: Substrate, Stimulus, or Both? N/A
Recruiting NCT05443347 - Activity, Adiposity, and Appetite in Adolescents 2 Intervention N/A
Terminated NCT04239482 - Nutritional Supplementation and Insulin Sensitivity N/A
Withdrawn NCT03452267 - Insulin Signaling in Skeletal Muscle Phase 2/Phase 3