Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/06/2007
Date assigned
30/08/2007
Last edited
30/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M Diamant

ORCID ID

Contact details

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

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

http://www.vumc.nl/english/

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

Publication citations

Additional files

Editorial Notes