Postprandial Dysmetabolism (PPDysMet)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Aarhus University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Diabetesforeningen
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00813215
First received: December 19, 2008
Last updated: March 7, 2011
Last verified: December 2008
  Purpose

Type 2 diabetes (T2D) is a common disease associated with multiple complications and an increased risk of cardiovascular morbidity and mortality. Also, it is a heavy economical burden on society. 1st degree relatives of patients with T2D have an increased risk of developing T2D. This risk can be modified by the ingested diet: a traditional north European diet rich in saturated fat increases the risk, while a Mediterranean diet rich in monounsaturated fat protects from development of T2D and cardiovascular disease.

T2D is a part of the metabolic syndrome consisting of T2D, hypertension, adipositas, dyslipidemia and steatosis. The pathogenesis of the metabolic syndrome is partly explained by fasting dyslipidemia, postprandial dysmetabolism (derangement of lipid and carbohydrate metabolism) and impaired metabolic flexibility. Partly, it can be explained by a chronic low-grade inflammation in peripheral tissue. The dysmetabolism and the inflammation are correlating entities exerting their influence through common biochemical pathways. This is established in patients with T2D, but sparsely studied in healthy relatives of patients with T2D.

In this project, the investigators will study postprandial dysmetabolism, inflammation, oxidative stress, adipocytokines, incretins, appetite regulating hormones and the expression of the genes involved in above mentioned. We will compare healthy 1st degree relatives of patients with T2D with healthy controls with no family history of T2D and look into differences in the response to meal stimulation with respectively saturated and monounsaturated fat. The subjects will be thoroughly examined with a hyperinsulinaemic euglycaemic clamp and a DEXA scan. Before and after the meal stimulation, we will perform calorimetry (in order to determine the metabolic rates), take blood samples and perform muscle and fat tissue biopsies. The biopsies will be used for studies of a vast number of genes.

The project will give us new valuable knowledge about the interaction between the intermediate metabolism and the innate immune system and the early pre-diabetic changes in the 1st degree relatives of patients with T2D. In the long run, the project will contribute to improving our guidance and treatment of persons at risk of developing T2D.


Condition Intervention
Type 2 Diabetes Mellitus
Dietary Supplement: Meal challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Postprandial Dysmetabolism - The Effects of Monounsaturated vs. Saturated Lipids on Lipid and Carbohydrate Metabolism and Inflammation in Healthy 1st Degree Relatives of Patients With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Incremental AUC og the triglyceride response [ Time Frame: 6 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gene expression of genes involved in lipid metabolism and inflammation [ Time Frame: 6 hrs ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: January 2009
Estimated Study Completion Date: August 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Relatives to patients with type 2 diabetes.
Dietary Supplement: Meal challenge
Meal challenge with a test meal rich on saturated fat.
Dietary Supplement: Meal challenge
Meal challenge with a test meal rich on monounsaturated fat
Active Comparator: 2
Controls with no family history of type 2 diabetes.
Dietary Supplement: Meal challenge
Meal challenge with a test meal rich on saturated fat.
Dietary Supplement: Meal challenge
Meal challenge with a test meal rich on monounsaturated fat

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Relatives: Minimum 2 1st degree relatives with type 2 diabetes or 1 one 1st degree relative with type 2 diabetes and history of gestational diabetes.
  • Controls: No family history of type 2 diabetes and fasting blood glucose <6.0 mM.

Exclusion Criteria:

  • Cardiovascular, renal or endocrine disease.
  • Treatment with steroids.
  • Psychiatric history.
  • Abuse of alcohol or narcotics.
  • Smoking.
  • Pregnancy or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813215

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
Diabetesforeningen
  More Information

No publications provided

Responsible Party: Professor Kjeld Hermansen, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00813215     History of Changes
Other Study ID Numbers: CERN-PPDysMet-AP
Study First Received: December 19, 2008
Last Updated: March 7, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Type 2 diabetes mellitus
Postprandial dysmetabolism
Postprandial inflammation
Relatives
Meal challenge

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014