Clinical trial NCT00401453: OatMeal and Insulin Resistance: OMA-IR
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Insulin Resistance
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: daily insulin requirements and glycemic control
timeFrame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention
Secondary outcomes:
measure: Changes in factors related to insulin resistance:
timeFrame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention
measure: free fatty acids, leptin, sOB-R, proinsulin, uric acid, adiponectin and high molecular weight adiponectin.
timeFrame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention
measure: Changes in markers of inflammation and macrovascular risk:
timeFrame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention
measure: c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL.
timeFrame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Fifth Medical Clinic
state: Baden-Wuerttemberg
Study officials:
affiliation: fifth medical clinic, university hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
name: Hans-Peter Hammes, PhD
role: STUDY_DIRECTOR
affiliation: fifth medical clinic, University hospital Mannheim, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany
name: Alexander Lammert, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/S0140-6736(05)61032-X.
citation: 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. doi: 10.2337/dc06-9913. No abstract available.
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. doi: 10.1055/s-2007-984456. Epub 2007 Dec 20.