Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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
...
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
Age 18-60 years old
Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone
Male

Exclusion Criteria

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

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

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
...
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
Age 18-60 years old
Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone
Male

Exclusion Criteria

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

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