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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03316690
Other study ID # H-17012307
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2017
Est. completion date October 1, 2018

Study information

Verified date November 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
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 training with and without concomitant metformin treatment, in order to investigate whether an interaction between the two occur.

Subjects with impaired glucose tolerance will all undergo 12 weeks of training but will be randomized (1:1) to concomitant metformin/placebo treatment in a double-blinded way. Experimental days will be performed before randomisation (before initiation of metformin/placebo treatment), before initiation of the training period and after the training period.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 1, 2018
Est. primary completion date October 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 reduce 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

Study Design


Intervention

Drug:
Metformin treatment
Daily treatment with metformin tablets for 101 days according to the following scheme: Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-101: Metformin tablet 1000 mg x 2
Placebo treatment
Daily treatment with placebo tablets for 101 days according to the following scheme: Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-101: Placebo tablet 1000 mg x 2
Behavioral:
Physical training
Twelve weeks of supervised physical training (4 times per week, 45 min per session, mean intensity at 70% of maximal oxygen consumption rate)

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 Change in postprandial glycemic control as assessed by mean blood glucose concentration during a 4 hour mixed-meal tolerance test Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in free-living glycemic control Blood HbA1c levels Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in endogenous glucose production as assessed by rate of infused glucose tracer appearance in blood Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in exogenous glucose uptake as assessed by rate of ingested glucose tracer appearance in blood Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in peripheral glucose uptake as assessed by rate of glucose disappearance from blood Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in maximal oxygen consumption Maximal oxygen uptake during an incremental bicycle test Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in body weight Body weight measured by standard procedures Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in lean body mass Lean body mass evaluated via Dual energy x-ray absorptiometry (Dxa) Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in total fat mass Total body fat mass evaluated via Dual energy x-ray absorptiometry (Dxa) Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in visceral fat mass Visceral fat mass evaluated via magnetic resonance imaging (MRI) scans Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in AMPK activity in skeletal muscle AMPK activity measured via western blotting and activity assays Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in skeletal muscle oxidative stress Muscle mitochondrial oxidative stress measured via respirometry in muscle biopsies Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Change in systemic oxidative stress Systemic oxidative stress measured via RNA/DNA oxidation products in urine Day 0 (before randomisation), 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Maximal mitochondrial respiration Maximal mitochondrial respiration measured via respirometry in muscle biopsies Day 17 (after initiation of metformin/placebo treatment), 101 (after 12 weeks of training)
Secondary Training heart rate Heart rate will be measured continuously during all training sessions Average heart rate during all training sessions (through study completion, [Day 101])
Secondary Training rate of perceived exertion Rate of perceived exertion measured via a Borg scale (range 6-20 where higher values indicate higher rate of perceived exertion) will be assessed for each training session Average rate of perceived exertion of all training sessions (through study completion, [Day 101])
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