The use of magnetic resonance in non-invasive pancreatic beta-cell imaging: the relation between pancreatic triglyceride accumulation and beta-cell function in human (pre)diabetes
ISRCTN | ISRCTN91251359 |
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DOI | https://doi.org/10.1186/ISRCTN91251359 |
Secondary identifying numbers | 2006/219 sub1 |
- Submission date
- 08/06/2007
- Registration date
- 30/08/2007
- Last edited
- 30/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Diamant
Scientific
Scientific
VU University Medical Center
Deparment of Endocrinology/ Diabetes Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Study information
Study design | Observational study. |
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Primary study design | Observational |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | Pancreatic triglyceride accumulation, measured by magnetic resonance spectroscopy, is related to beta-cell function in subjects with Impaired Glucose Tolerance and/or Impaired Fasting Glucose. |
Ethics approval(s) | Ethics Committee VU University Medical Center 18-12-2006 (ref: 2006/219) |
Health condition(s) or problem(s) studied | Subjects with impaired glucose tolerance and/or impaired fasting glucose |
Intervention | The following will be performed in each subject: 1. A modified euglycaemic hyperglycaemic clamp with arginine stimulation (After an euglycaemic clamp [120 minutes, 5 mmol/L], there is an hour rest period followed by a hyperglycaemic clamp [110 minutes, 15 mmol/L with 5 grams arginine stimulation]) 2. Magnetic Resonance Imaging (MRI) of the abdominal fat compartments 3. Proton Magnetic Resonance Spectroscopy (1H-MRS) |
Intervention type | Other |
Primary outcome measure | 1. Triglyceride content of the human pancreas in vivo assessed using non-invasive 1H-MRS 2. Relation between pancreatic triglyceride accumulation and beta-cell function 3. Relation between triglyceride accumulation in the pancreas and other fat compartments within the abdomen |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/04/2007 |
Completion date | 01/04/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 40 |
Key inclusion criteria | 1. Male and female subjects (aged 35-70 years) 2. Impaired Fasting Glucose (IFG; plasma glucose > = 6.1 and < 7.0 mmol/l) and/or 3. IFG (plasma glucose >= 5.6 and < 7.0 mmol/l) and a family history of Diabetes Mellitus type two (DM2; i.e. first and second degree [i.e. grandparents] relatives) and/or 4. Impaired Glucose Tolerance (IGT; 2-hour plasma glucose during 75 g Oral Glucose Tolerance Test [OGTT] 7.8-11.1 mmol/l) |
Key exclusion criteria | 1. Known diabetes 2. History or present liver, exocrine pancreatic or renal disease 3. Drug-/alcohol abuse 4. Acute cardiovascular disease <3 months prior to screening 5. Malignant disease 6. Claustrophobia and metal implants or pacemakers (MRI) 7. Lack of capacity to understand the aim of the research 8. Use of the following: 8.1. Glucocorticoids 8.2. Cytostatic drugs 8.3. Thiazolidinediones 8.4. Metformin 8.5. Oral contraceptives 8.6. Fibrates 8.7. Anti epileptic drugs 8.8. Centrally acting drugs for neurologic and/or psychiatric indications |
Date of first enrolment | 01/04/2007 |
Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
VU University Medical Center, Diabetes Center (The Netherlands)
University/education
University/education
c/o Dr M Diamant
VU University Medical Center
Deparment of Endocrinology / Diabetes Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Website | http://www.vumc.nl/english/ |
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https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
Merck Sharp & Dohme B.V. Protocol number: P 2129 V1 (International)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |