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Xanthine Oxidase Inhibitor
Allopurinol for Type 2 Diabetes
Phase 2
Waitlist Available
Led By Camila Manrique Acevedo, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months (final). the goal is to assess changes from baseline when compared to final time point.
Awards & highlights
Study Summary
This trial will test three interventions to see if they can improve pulse wave velocity in men and women with type 2 diabetes. The first group will take allopurinol to reduce serum uric acid, the second group will restrict dietary fructose, and the third group will restrict dietary fructose and also achieve a caloric deficit.
Eligible Conditions
- Type 2 Diabetes
- High Uric Acid
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months (final). the goal is to assess changes from baseline when compared to final time point.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months (final). the goal is to assess changes from baseline when compared to final time point.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Carotid Femoral Pulse Wave Velocity (cfPWV)
Secondary outcome measures
Brachial Artery Flow Mediated Dilation (FMD)
Insulin-stimulated Leg Blood Flow
Side effects data
From 2019 Phase 3 trial • 530 Patients • NCT0201717116%
Rash
12%
Upper respiratory tract infection
10%
Hypoglycaemia
7%
Nasopharyngitis
6%
Urinary tract infection
6%
Influenza like illness
6%
Sinusitis
6%
Diabetic ketoacidosis
5%
Pain in extremity
4%
Bronchitis
3%
Acute myocardial infarction
2%
Osteomyelitis
2%
Abortion spontaneous
1%
Diarrhoea
1%
Myocardial infarction
1%
Cardiac failure congestive
1%
Diabetic gastroparesis
1%
Chest pain
1%
Pancreatitis acute
1%
Asthma
1%
Coronary artery disease
1%
Gastrointestinal haemorrhage
1%
Pneumonia
1%
Cardiac arrest
1%
Hyperglycaemia
1%
Death
1%
Cellulitis
1%
Staphylococcal infection
1%
Road traffic accident
1%
Renal failure acute
1%
Pregnancy
1%
Skin ulcer
1%
Amputation
1%
Hyperemesis gravidarum
1%
Angina unstable
1%
Impaired gastric emptying
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Allopurinol
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Low-fructose diet, isocaloricExperimental Treatment1 Intervention
Subjects assigned to this arm of the study will consume for 6 months a diet low in fructose while maintaining baseline body weight.
Group II: Low-fructose diet, hypocaloricExperimental Treatment1 Intervention
Subjects assigned to this arm of the study will consume for 6 months a diet low in fructose with a 500 Calorie energy reduction.
Group III: AllopurinolExperimental Treatment1 Intervention
Subjects assigned to this arm of the study will be treated for 6 months with allopurinol (max dose 300 mg)
Group IV: PlaceboPlacebo Group1 Intervention
Subjects assigned to this arm will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allopurinol
FDA approved
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
361 Previous Clinical Trials
627,960 Total Patients Enrolled
Camila Manrique Acevedo, MDPrincipal InvestigatorUniversity of Missouri-Columbia
2 Previous Clinical Trials
209 Total Patients Enrolled
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