Investigation of a new way for sugar uptake by the skeletal muscle in obese humans

Phase 1

• Conditions: Type 2 diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2021-000731-31-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-08
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Male or (postmenopausal; defined as 1 year after the last cycle) female;
2.Age between 40-70 years;
3.BMI: 27-35 kg/m2;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.Not meeting all inclusion criteria
2.Cardiovascular disease (determined by means of questionnaires, heart rate/blood pressure measurements and an ECG)
3.Respiratory diseases (including asthma, bronchitis and COPD);
4.Unstable body weight (weight gain or loss > 5 kg in the last three months);
5.Intention to lose or gain body weight (e.g. with caloric restriction or physical activity)
6.Excessive alcohol and/or drug abuse;
7.Hypokalaemia;
8.Hyperthyroidism
9.Anaemia;
10.Epilepsy;
11.Smoking;
12.Renal and/or liver insufficiency;
13.Diagnosed with type 1 or type 2 diabetes mellitus;
14.Any contra-indications to MRI scanning. These contra-indications include patients with:
a.Electronic implants such as pacemakers, defibrillators or neurostimulators
b.Central nervous system aneurysm clip
c.Some hearing aids (such as cochlear implant) and artificial (heart) valves which are contraindicated for MRI/MRS
d.Iron containing corpora aliena in the eye or brains
e.Claustrophobia
15.Participation in another biomedical study within 1 month before the first study visit, possibly interfering with the study results;
16.Medication use known to hamper subject’s safety during the study procedures; ?
17.Subjects who do not want to be informed about unexpected medical findings; ?
18.Subjects who do not want that their treating physician to be informed;
19.Inability to participate and/or complete the required measurements;
20.Participation in organised or structured physical exercise;
21.Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified