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University Hospital Mannheim |
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Information provided by: | University Hospital Mannheim |
ClinicalTrials.gov Identifier: | NCT00401453 |
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 |
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Diabetes Mellitus Type 2 Insulin Resistance |
Behavioral: Diet: carbohydrate days. (Name: oatmeal.) |
Phase III |
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). |
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) |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alexander Lammert, MD | +49-621-3833370 | alexander.lammert@med5.ma.uni-heidelberg.de |
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 |
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 |
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 |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |