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
  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.

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Insulin Resistance
Behavioral: Diet: carbohydrate days. (Name: oatmeal.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin 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
Study Completion Date: February 2010
Primary Completion Date: February 2010 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00401453

Locations
Germany
Fifth Medical Clinic
Mannheim, Baden-Wuerttemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin 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: Alexander Lammert, Universty Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00401453     History of Changes
Other Study ID Numbers: 2006-119N-MA
Study First Received: November 17, 2006
Last Updated: February 16, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014