Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Age 18-60 years old
Body mass index (BMI) 27-37 kg/m2
Understand verbal and/or written explanation of the study requirements
...
Age 18-60 years old
Body mass index (BMI) 27-37 kg/m2
Understand verbal and/or written explanation of the study requirements
Not taking anti-diabetes medication other than metformin
Male
Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone

Exclusion Criteria

Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
Active gastrointestinal or liver disease
Metabolic diseases (stable treated hypothyroidism allowed)
...
Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
Active gastrointestinal or liver disease
Metabolic diseases (stable treated hypothyroidism allowed)
Active respiratory disease
Any other conditions in addition to the above that the investigators consider may affect study measurements or safety
Malignancy (excluding localised basal and squamous cell skin cancer)
Primary muscle disorders
Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months)
Clotting dysfunction
Cerebrovascular disease
Neurological disease e.g. epilepsy, Parkinsons disease
Renal impairment (eGFR <60 ml/min)
Anti-diabetes medication other than metformin

Summary

Conditions
Type 2 Diabetes
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 60 years
Gender
Only males

Inclusion Criteria

Age 18-60 years old
Body mass index (BMI) 27-37 kg/m2
Understand verbal and/or written explanation of the study requirements
...
Age 18-60 years old
Body mass index (BMI) 27-37 kg/m2
Understand verbal and/or written explanation of the study requirements
Not taking anti-diabetes medication other than metformin
Male
Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone

Exclusion Criteria

Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
Active gastrointestinal or liver disease
Metabolic diseases (stable treated hypothyroidism allowed)
...
Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants)
Active gastrointestinal or liver disease
Metabolic diseases (stable treated hypothyroidism allowed)
Active respiratory disease
Any other conditions in addition to the above that the investigators consider may affect study measurements or safety
Malignancy (excluding localised basal and squamous cell skin cancer)
Primary muscle disorders
Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months)
Clotting dysfunction
Cerebrovascular disease
Neurological disease e.g. epilepsy, Parkinsons disease
Renal impairment (eGFR <60 ml/min)
Anti-diabetes medication other than metformin

Locations

Nottingham, NG72UH
Nottingham, NG72UH

Tracking Information

NCT #
NCT02197299
Collaborators
Not Provided
Investigators
  • Principal Investigator: Francis B Stephens, PhD The University of Nottingham
  • Francis B Stephens, PhD The University of Nottingham