NCT03458741

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

February 15, 2018

Last Update Submit

March 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

The subjects arrived in the morning in the overnight fasted state at day 1, day 2 and day 5. Upon arrival in the morning the subjects were given a meal corresponding to 5% of their daily energy intake (\~600-800 kJ). 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.

Eligibility Criteria

Age25 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition, Exercise and Sports

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 8, 2018

Study Start

September 5, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

March 8, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations