Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Obesity Clinical Trial

Official title:

Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805802
• Other study ID #: 012019
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: October 2020
• Source: Stoffwechselzentrum Rhein - Pfalz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.

Description:

It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes with inadequate glucose control and a HbA1c >7,5 and < 9%
• Treatment with all oral antidiabetic medication or injectable GLP-1 analogues
• BMI 28,0-39,9 kg/m²
• Age 30-70 years

Exclusion Criteria:

• insulin treatment
• Psychiatric Disease
• Acute Infections
• Alcohol or drug abuse
• Acute diverticulitis
• Malignant tumors or hematologic disorders
• Heart failure NYHA III-IV
• Acute coronary syndrome
• Chronic kidney disease > Stage 3 (KDOQI)
• Pregnancy or Lactation
• Previous bariatric interventions

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Obesity
• Overweight

Intervention

Other:
• active product
Once daily consumption over the period of the study
• reference product
Once daily consumption over the period of the study

Locations

Country	Name	City	State
Germany	Stoffwechselzentrum Rhein-Pfalz	Mannheim	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Stoffwechselzentrum Rhein - Pfalz	Glucanova AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic lood pressure	Systolic blood pressure left arm 6 weeks in mm/Hg	6 weeks
Other	Diastolic blood pressure	Diastolic blood pressure left arm 6 weeks in mm/Hg	6 weeks
Other	Systolic blood pressure	Systolic blood pressure left arm 12 weeks in mm/Hg	12 weeks
Other	Diastolic blood pressure	Diastolic blood pressure left arm 12 weeks in mm/Hg	12 weeks
Other	Waist circumference	Waist circumference at 6 weeks in cm	6 weeks
Other	Waist circumference	Waist circumference at 12 weeks in cm	12 weeks
Primary	Fasting glucose	Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.	6 weeks
Secondary	Fasting glucose	Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.	12 weeks
Secondary	HBA1c	long-term glucose control as measured by the concentratino of HbA1c concentration in %	6 weeks
Secondary	HBA1c	long-term glucose control as measured by the concentratino of HbA1c concentration in %	12 weeks
Secondary	Self-documented glucose	Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl	6 weeks
Secondary	Self-documented glucose	Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl	12 weeks
Secondary	Weight	Chenge in body Weight in kg	6 weeks
Secondary	Weight	Chenge in body Weight in kg	12 weeks
Secondary	BMI	Body Mass Index	6 weeks
Secondary	BMI	Body Mass Index	12 weeks
Secondary	Lipid metabolism: Serum triglycerides	Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)	6 weeks
Secondary	Lipid metabolism: Serum triglycerides	Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)	12 weeks
Secondary	Lipid metabolism: apolipoprotein A (mg/dl)	Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)	6 weeks
Secondary	Lipid metabolism: apolipoprotein A (mg/dl)	Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)	12 weeks
Secondary	Lipid metabolism: Apolipoprotein B mg/dl	Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl	6 weeks
Secondary	Lipid metabolism: Apolipoprotein B mg/dl	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl	12 weeks
Secondary	Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio	Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio	6 weeks
Secondary	Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio	12 weeks
Secondary	Lipid metabolism: HDL-cholesterol	Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl	6 weeks
Secondary	Lipid metabolism: HDL-cholesterol	Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl	12 weeks
Secondary	Lipid metabolism: LDL- cholesterol mg/dl	Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl	6 weeks
Secondary	Lipid metabolism: LDL- cholesterol mg/dl	Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl	12 weeks
Secondary	Microbiome	Microbiome in faeces samples at 6 weeks	6 weeks
Secondary	Microbiome	Microbiome in faeces samples at 12 weeks	12 weeks
Secondary	Inflammation: Il-6	Markers of inflammation at 6 weeks IL-6 in ng/ml	6 weeks
Secondary	Inflammation: hsCRP	Markers of inflammation at 6 weeks hsCRP mg/l	6 weeks
Secondary	Inflammation: Il-6	Markers of inflammation at 12 weeks IL-6 in ng/ml	12 weeks
Secondary	Inflammation: hsCRP	Markers of inflammation at 12 weeks hsCRP mg/l	12 weeks