Glucotoxicity and Acute Exercise

Type 2 Diabetes Clinical Trial

Official title:

The Effects of Hyperglycaemia on the Response to Acute Exercise

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01771614
• Other study ID #: GlucotoxEx
• Status: Withdrawn
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: May 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. The effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. Changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion criteria for participation:

• Male

• Age 18-50 years

• Body Mass Index 19-30 kg/m2

• Generally healthy

Exclusion criteria for participation:

• Regular use of anti-inflammatory medication

• Smokers

• More than 2 kg weight change in prior 6 months

• Previous weight loss surgery

• Cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease

• Evidence of diabetes

• Engaged in moderate or vigorous activity on more than 5 days per week

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Behavioral:
• Exercise

Procedure:
• Hyperglycemia

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic endocrine function	The plasma insulin, C-peptide, and glucagon responses to a 0.33 g/kg intravenous glucose tolerance test (IVGTT) will be measured. In each trial, the IVGTT will be performed at T = 0, 6, 7, 9, and 24 hours.	0, 6, 7, 9, and 24 hours
Secondary	Glucose tolerance	Glucose tolerance will be measured during an IVGTT in each trial at T = 0, 6, 7, 9, and 24 hours.	0, 6, 7, 9, and 24 hours
Secondary	Endothelial function	Blood flow and flow-mediated dilation by Doppler ultrasound will be measured in each trial at T = 0, 6, 7, 9, and 24 hours.	0, 6, 7, 9, and 24 hours
Secondary	Oxidative stress	Urine will be collected over the whole 24-hour period of each trial and 8-iso Prostaglandin F3a will be measured.	24 hours