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
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

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

Study information

Study designObservational study.
Primary study designObservational
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesPancreatic 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) studiedSubjects with impaired glucose tolerance and/or impaired fasting glucose
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/04/2007
Completion date01/04/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2007
Date of final enrolment01/04/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center
Amsterdam
1081 HV
Netherlands

Sponsor information

VU University Medical Center, Diabetes Center (The Netherlands)
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/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan