The Interaction Between Metformin and Acute Exercise

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Interaction Between Metformin and Acute Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329651
• Other study ID #: H-17012307-1
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: October 1, 2018

Study information

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

Clinical Trial Summary

Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however, the vast majority of patients with T2D do not achieve satisfying glycemic control with physical activity alone, which is why pharmacological treatment with metformin is most often initiated.

It is known that metformin and exercise both activates 5' adenosine monophosphate-activated protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in many different metabolic effects, including improvements in glycemic control. Because of this similarity in mechanism of action, an interaction between metformin and exercise is plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the effects of acute physical activity with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.

Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo treatment in a double-blinded way. Following a treatment run-in period of 17 days, two experimental days (one with acute exercise and one without acute exercise), separated by one week, will be performed in each subject.

This registration concerns a sub-study of another study which has previously been registrered at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this registration have not previously been registered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Glucose-lowering-medication naïve T2D and/or subjects with impaired glucose tolerance defined as: 2-h plasma glucose (PG) in the 75-g OGTT (7.8-11.0 mmol/L) and/or HbA1c (39-47 mmol/mol)

• Caucasian

• BMI > 25 but < 40 kg/m2

• Low to moderate physically active (=90 min of structured physical activity/week)

Exclusion Criteria:

• Pregnancy

• Smoking

• Glucose-lowering treatment

• Treatment with steroids and other immunomodulating drugs

• Contraindication to increased levels of physical activity

• Liver disease (ALAT elevated more than 3 times above upper normal limit, or reduced levels of the liver function markers albumin and KF II+VII+X)

• Renal insufficiency (eGFR<60 ml/min)

• Prior history of lactic acidosis

• HbA1c >55 mmol/mol and/or 2-hPG in the 75-g OGTT > 15 mmol/L

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• Metformin treatment
Daily treatment with metformin tablets for 24 days according to the following scheme: Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-24: Metformin tablet 1000 mg x 2
• Placebo treatment
Daily treatment with placebo tablets for 24 days according to the following scheme: Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-24: Placebo tablet 1000 mg x 2

Locations

Country	Name	City	State
Denmark	Center for aktiv sundhed	Copenhagen	Copenhagen N

Sponsors (2)

Lead Sponsor	Collaborator
Kristian Karstoft	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test		Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Secondary	Difference in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood		Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Secondary	Difference in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood		Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)
Secondary	Difference in peripheral glucose uptake as assessed by rate of glucose disappearance from blood		Day 17 (no acute exercise [control day]) and 24 (following an acute exercise bout)