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
DOI	https://doi.org/10.1186/ISRCTN91251359
Protocol serial number	2006/219 sub1
Sponsor	VU University Medical Center, Diabetes Center (The Netherlands)
Funder	Merck Sharp & Dohme B.V. Protocol number: P 2129 V1 (International)

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

Dr M Diamant
Scientific

VU University Medical Center
Deparment of Endocrinology/ Diabetes Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Primary study design	Observational
Study design	Observational study.
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2009

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

VU University Medical Center

Amsterdam
1081 HV
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan