OatMeal and Insulin Resistance: OMA-IR

Insulin Resistance Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401453
• Other study ID #: 2006-119N-MA
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2006
• Last updated: February 16, 2010
• Start date: January 2007
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

Behavioral:
• Diet: carbohydrate days. (Name: oatmeal.)
Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.

Locations

Country	Name	City	State
Germany	Fifth Medical Clinic	Mannheim	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (4)

ACE/ADA Task Force on Inpatient Diabetes. American College of Endocrinology and American Diabetes Association Consensus statement on inpatient diabetes and glycemic control. Diabetes Care. 2006 Aug;29(8):1955-62. Review. — View Citation

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602. — View Citation

Lammert A, Kratzsch J, Selhorst J, Humpert PM, Bierhaus A, Birck R, Kusterer K, Hammes HP. Clinical benefit of a short term dietary oatmeal intervention in patients with type 2 diabetes and severe insulin resistance: a pilot study. Exp Clin Endocrinol Diabetes. 2008 Feb;116(2):132-4. Epub 2007 Dec 20. — View Citation

Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet. 2005 Apr 9-15;365(9467):1333-46. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily insulin requirements and glycemic control		directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention	No
Secondary	Changes in factors related to insulin resistance:		directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention	No
Secondary	free fatty acids, leptin, sOB-R, proinsulin, uric acid, adiponectin and high molecular weight adiponectin.		directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention	No
Secondary	Changes in markers of inflammation and macrovascular risk:		directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention	No
Secondary	c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL.		directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention	No