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OatMeal and Insulin Resistance: OMA-IR
This study is currently recruiting participants.
Verified by University Hospital Mannheim, June 2008
Sponsored by: University Hospital Mannheim
Information provided by: University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00401453
  Purpose

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.

We 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 we 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. We 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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Insulin Resistance
Behavioral: Diet: carbohydrate days. (Name: oatmeal.)
Phase III

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Carbohydrate Days as Simple and Efficient Therapy for Patients With Type 2 Diabetes Mellitus and Insulin Resistance: Oatmeal and Insulin Resistance (OMA-IR).

Further study details as provided by University Hospital Mannheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: January 2007
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Diet: carbohydrate days. (Name: oatmeal.)
    Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401453

Contacts
Contact: Alexander Lammert, MD +49-621-3833370 alexander.lammert@med5.ma.uni-heidelberg.de

Locations
Germany, Baden-Wuerttemberg
Fifth Medical Clinic Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Contact: Alexander Lammert, MD     +49-621-3833370     alexander.lammert@med5.ma.uni-heidelberg.de    
Principal Investigator: Alexander Lammert, MD            
Sub-Investigator: Jochen Selhorst, MD            
Sub-Investigator: Jill Augustin, MD            
Sub-Investigator: Rainer Birck, PhD            
Sponsors and Collaborators
University Hospital Mannheim
Investigators
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
  More Information

Publications:
Responsible Party: Universty Hospital Mannheim ( Alexander Lammert )
Study ID Numbers: 2006-119N-MA
Study First Received: November 17, 2006
Last Updated: June 3, 2008
ClinicalTrials.gov Identifier: NCT00401453  
Health Authority: Germany: Ethics Commission

Study placed in the following topic categories:
Hyperinsulinism
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009