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OatMeal and Insulin Resistance: OMA-IR

This study has been completed.
Sponsor:
Information provided by:
Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier:
NCT00401453
First received: November 17, 2006
Last updated: February 16, 2010
Last verified: February 2010

November 17, 2006
February 16, 2010
January 2007
February 2010   (final data collection date for primary outcome measure)
daily insulin requirements and glycemic control [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] [ Designated as safety issue: No ]
daily insulin requirements and glycemic control
Complete list of historical versions of study NCT00401453 on ClinicalTrials.gov Archive Site
  • Changes in factors related to insulin resistance: [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] [ Designated as safety issue: No ]
  • free fatty acids, leptin, sOB-R, proinsulin, uric acid, adiponectin and high molecular weight adiponectin. [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] [ Designated as safety issue: No ]
  • Changes in markers of inflammation and macrovascular risk: [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] [ Designated as safety issue: No ]
  • c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL. [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] [ Designated as safety issue: No ]
  • Changes in factors related to insulin resistance:
  • free fatty acids, leptin, sOB-R, proinsulin, uric acid, adiponectin and high molecular weight adiponectin.
  • Changes in markers of inflammation and macrovascular risk:
  • c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL.
Not Provided
Not Provided
 
OatMeal and Insulin Resistance: OMA-IR
Carbohydrate Days as Simple and Efficient Therapy for Patients With Type 2 Diabetes Mellitus and Insulin Resistance: Oatmeal and Insulin Resistance (OMA-IR).

Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005). Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al. 2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet 1998).

A long known therapy for the acute treatment of patients with deteriorated glucose metabolism and insulin resistance are carbohydrate days. The principle of the therapy was firstly introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly, this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up to now there has been no systemic evaluation of carbohydrate days in patients with deteriorated Diabetes mellitus and insulin resistance.

The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and after a four week outpatient period. Inclusion criteria were type 2 diabetes with deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than 1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked decrease of insulin requirements (~40%) and mean daily blood glucose to a mean blood glucose of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period (Lammert et al. 2006).

The most important shortcomings of this study were the hypocaloric interventions in both groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These design flaws have been addressed within this new clinical trial. The investigators plan an open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted diet: ~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day) within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus Type 2
  • Insulin Resistance
Behavioral: Diet: carbohydrate days. (Name: oatmeal.)
Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diabetes mellitus 2
  • insulin therapy
  • stable therapy modality within the last 3 months
  • deteriorated glucose metabolism (Hba1c > 7%)
  • insulin resistance, defined as more than 1 unit of insulin per kg and day

Exclusion Criteria:

  • acute vascular event within the last 3 months
  • planed weight reducing therapy
  • acute and chronic inflammatory disease
  • therapy with corticosteroids
  • pregnancy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00401453
2006-119N-MA
Not Provided
Alexander Lammert, Universty Hospital Mannheim
Universitätsmedizin Mannheim
Not Provided
Study Director: Hans-Peter Hammes, PhD fifth medical clinic, university hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
Principal Investigator: Alexander Lammert, MD fifth medical clinic, University hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
Universitätsmedizin Mannheim
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP