Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006/219 sub1
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics Committee VU University Medical Center 18-12-2006 (ref: 2006/219)
Study design
Observational study.
Primary study design
Observational
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2007
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
VU University Medical Center, Diabetes Center (The Netherlands)
Sponsor details
c/o Dr M Diamant
VU University Medical Center
Deparment of Endocrinology / Diabetes Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Merck Sharp & Dohme B.V. Protocol number: P 2129 V1 (International)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary