Postprandial Dysmetabolism

NCT ID: NCT00813215

Last Updated: 2011-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

1

Relatives to patients with type 2 diabetes.

Group Type: EXPERIMENTAL

Meal challenge

Intervention Type: DIETARY_SUPPLEMENT

Meal challenge with a test meal rich on saturated fat.

Meal challenge

Intervention Type: DIETARY_SUPPLEMENT

Meal challenge with a test meal rich on monounsaturated fat

2

Controls with no family history of type 2 diabetes.

Group Type: ACTIVE_COMPARATOR

Meal challenge

Intervention Type: DIETARY_SUPPLEMENT

Meal challenge with a test meal rich on saturated fat.

Meal challenge

Intervention Type: DIETARY_SUPPLEMENT

Meal challenge with a test meal rich on monounsaturated fat

Interventions

Meal challenge

Meal challenge with a test meal rich on saturated fat.

Intervention Type: DIETARY_SUPPLEMENT

Meal challenge

Meal challenge with a test meal rich on monounsaturated fat

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diabetesforeningen

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

CERN-PPDysMet-AP

Identifier Type: -

Identifier Source: org_study_id