PPDysMet: Postprandial Dysmetabolism

Sponsor

Aarhus University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00813215

Collaborator

Diabetesforeningen (Other)

Enrollment

Location

Arms

30.9

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Dietary Supplement: Meal challenge Dietary Supplement: Meal challenge	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

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.

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Anticipated Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Incremental AUC og the triglyceride response [6 hrs]

Secondary Outcome Measures

Gene expression of genes involved in lipid metabolism and inflammation [6 hrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.