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Diabetes Mellitus Type 2Phase 3NCT00401453

OatMeal and Insulin Resistance: OMA-IR

A Phase 3 study testing Diet: carbohydrate days. (Name: oatmeal.) in people with Diabetes Mellitus Type 2 and Insulin Resistance, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetes Mellitus Type 2, Insulin Resistance
What is being tested?
Diet: carbohydrate days. (Name: oatmeal.)
How many people
15 participants
Where
1 siteGermany
Study dates
Jan 2007to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • acute vascular event within the last 3 months
  • planed weight reducing therapy
  • acute and chronic inflammatory disease
  • therapy with corticosteroids
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Fifth Medical Clinic

    Mannheim, Baden-Wurttemberg, 68167

Other trials in Germany

About this 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).

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.

Read more

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.

Being tested
Diet: carbohydrate days. (Name: oatmeal.)
Medical subject headings
Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet: carbohydrate days. (Name: oatmeal.)Behavioural

    Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. daily insulin requirements and glycemic control

    Measured: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention

Secondary outcomes (4)

  1. Changes in factors related to insulin resistance:

    Measured: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention

  2. free fatty acids, leptin, sOB-R, proinsulin, uric acid, adiponectin and high molecular weight adiponectin.

    Measured: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention

  3. Changes in markers of inflammation and macrovascular risk:

    Measured: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention

  4. c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL.

    Measured: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401453
Sponsor's protocol ID
2006-119N-MA
Status last verified
Feb 2010
First submitted
17 Nov 2006
Last updated
17 Feb 2010
Results posted
No

Publications

  • 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.

    PubMed 9742976

  • 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.

    PubMed 15823385

  • 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.

    PubMed 16873812

  • 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.

    PubMed 18095234

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diet: carbohydrate days. (Name: oatmeal.) in people with Diabetes Mellitus Type 2 and Insulin Resistance, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

daily insulin requirements and glycemic control (time frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401453, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2010.

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