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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Diabetes Mellitus, Type 2; Overweight; Obesity
• Interventions: Other: active product; Other: reference product

• Registration Number: NCT03805802
• Lead Sponsor: Stoffwechselzentrum Rhein - Pfalz

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-13
• Study First Submitted QC: 2019-01-13
• Study First Posted: 2019-01-16
• Study Start: 2019-02-04
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reference product	active product	Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).
reference product	reference product	Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).
active product	active product	Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).

Primary Outcome Measures

Name	Time	Method
Fasting glucose	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Inflammation: Il-6	12 weeks	Markers of inflammation at 12 weeks IL-6 in ng/ml
HBA1c	12 weeks	long-term glucose control as measured by the concentratino of HbA1c concentration in %
Fasting glucose	12 weeks	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.
Self-documented glucose	12 weeks	Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl
Weight	12 weeks	Chenge in body Weight in kg
BMI	12 weeks	Body Mass Index
Lipid metabolism: Serum triglycerides	12 weeks	Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)
Lipid metabolism: apolipoprotein A (mg/dl)	12 weeks	Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)
Lipid metabolism: Apolipoprotein B mg/dl	12 weeks	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl
Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio	12 weeks	Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio
Lipid metabolism: HDL-cholesterol	12 weeks	Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl
Lipid metabolism: LDL- cholesterol mg/dl	12 weeks	Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl
Microbiome	12 weeks	Microbiome in faeces samples at 12 weeks
Inflammation: hsCRP	12 weeks	Markers of inflammation at 12 weeks hsCRP mg/l

Trial Locations

Locations (1)

Stoffwechselzentrum Rhein-Pfalz; 🇩🇪 Mannheim, Baden-Württemberg, Germany