- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723110
Defining the Physiological Mechanisms of Risk Genes for Hyperglycaemia, Insulin Resistance and Type 2 Diabetes (DIVA - PAM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Note: The study will utilize an adaptive study design with an interim analysis at 40 volunteers (20 v 20) with the possibility of adding an additional 20 volunteers to the study (10 v 10) if the criteria for futility or clear effect are not met.
The criteria are; stop and reject null hypothesis if t > 2.490 and stop and accept null hypothesis if t < 1.033. If the t falls between these values an additional 20 volunteers (10 v10) will be recruited. The decision to stop or additional volunteers will be based on the incretin effect (primary outcome).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fredrik Karpe
- Phone Number: 01865 857222
- Email: fredrik.karpe@ocdem.ox.ac.uk
Study Contact Backup
- Name: Mahesh M Umapathysivam
- Phone Number: 01865857261
- Email: mahesh.umapathysivam@spc.ox.ac.uk
Study Locations
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 7LE
- Recruiting
- OCDEM, University of Oxford
-
Contact:
- Fredrik Karpe
- Phone Number: 01865 857222
- Email: fredrik.karpe@ocdem.ox.ac.uk
-
Contact:
- Mahesh M Umapathysivam
- Email: mahesh.umapathysivam@spc.ox.ac.uk
-
Principal Investigator:
- Fredrik Karpe
-
Sub-Investigator:
- Mahesh Umapathysivam
-
Sub-Investigator:
- Anna Gloyn
-
Sub-Investigator:
- Mark McCarthy
-
Sub-Investigator:
- Patrik Rorsman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult, age 30-65 inclusive, healthy, appropriate genotype
- Mental capacity to consent
Exclusion Criteria:
- Demographics: <30 and >65 years old
- Medical history: Bariatric surgery, surgery on gut/ stomach; history of recent significant weight loss (>10% of weight in last year); known cardiovascular disease
- Medications: Currently prescribed glucose-lowering medication, oral/IV corticosteroid treatment, any medication effecting gastric motility or glucose metabolism
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
rs78408340 heterozygous carriers
|
Blood glucose level(BGL) every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
Other Names:
Glucose infusion over 4 hours to reproduce OGTT glucose curve to allow measurement of incretin effect.
BGL every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
Other Names:
|
homozygous non-risk allele carriers
|
Blood glucose level(BGL) every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
Other Names:
Glucose infusion over 4 hours to reproduce OGTT glucose curve to allow measurement of incretin effect.
BGL every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculated Incretin Effect
Time Frame: 3 months
|
Will be calculated from the amount of IV glucose required to reproduce OGTT glycaemic profile
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin concentration
Time Frame: 3 months
|
3 months
|
|
Glucose concentrations
Time Frame: 3 months
|
3 months
|
|
GLP-1 (glucagon-like peptide-1) amidated and unamidated concentration
Time Frame: 3 months
|
3 months
|
|
PAM enzyme activity assay
Time Frame: 3 months
|
This assay is based off the protocol in the published literature, and is based on the turnover of radio-labelled substrate to quantify the amidating ability of the PAM enzyme
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/SC/0072
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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