Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00401453
Status:
COMPLETED
Last Update Posted:
2010-02-17
First Post:
2006-11-17
Brief Title:
OatMeal and Insulin Resistance OMA-IR
Sponsor:
Universitätsmedizin Mannheim
Organization:
Universitätsmedizin Mannheim
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 its 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 1147367 mgdl 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 1500kcald vs oatmeal 1200kcald 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 1200kcald 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
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 its 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 1147367 mgdl 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 1500kcald vs oatmeal 1200kcald 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 1200kcald 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None