Clinical trial NCT03805802: Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Official title: Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Overweight
Metabolic Syndrome
Keywords: fiber
type 2 diabetes
dietary intervention
weight loss
glucose control
obesity
overweight
metabolic syndrome
oats
Lead sponsor: Stoffwechselzentrum Rhein - Pfalz
Sponsor class: OTHER
Collaborators: name: Glucanova AB
First posted: 2019-01-16
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fasting glucose
timeFrame: 6 weeks
Secondary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
measure: HBA1c
timeFrame: 6 weeks
measure: HBA1c
timeFrame: 12 weeks
measure: Self-documented glucose
timeFrame: 6 weeks
measure: Self-documented glucose
timeFrame: 12 weeks
measure: Weight
timeFrame: 6 weeks
measure: Weight
timeFrame: 12 weeks
measure: BMI
timeFrame: 6 weeks
measure: BMI
timeFrame: 12 weeks
measure: Lipid metabolism: Serum triglycerides
timeFrame: 6 weeks
measure: Lipid metabolism: Serum triglycerides
timeFrame: 12 weeks
measure: Lipid metabolism: apolipoprotein A (mg/dl)
timeFrame: 6 weeks
measure: Lipid metabolism: apolipoprotein A (mg/dl)
timeFrame: 12 weeks
measure: Lipid metabolism: Apolipoprotein B mg/dl
timeFrame: 6 weeks
measure: Lipid metabolism: Apolipoprotein B mg/dl
timeFrame: 12 weeks
measure: Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
timeFrame: 6 weeks
measure: Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio
timeFrame: 12 weeks
measure: Lipid metabolism: HDL-cholesterol
timeFrame: 6 weeks
measure: Lipid metabolism: HDL-cholesterol
timeFrame: 12 weeks
measure: Lipid metabolism: LDL- cholesterol mg/dl
timeFrame: 6 weeks
measure: Lipid metabolism: LDL- cholesterol mg/dl
timeFrame: 12 weeks
measure: Microbiome
timeFrame: 6 weeks
measure: Microbiome
timeFrame: 12 weeks
measure: Inflammation: Il-6
timeFrame: 6 weeks
measure: Inflammation: hsCRP
timeFrame: 6 weeks
measure: Inflammation: Il-6
timeFrame: 12 weeks
measure: Inflammation: hsCRP
timeFrame: 12 weeks
Other outcomes:
measure: Systolic lood pressure
timeFrame: 6 weeks
measure: Diastolic blood pressure
timeFrame: 6 weeks
measure: Systolic blood pressure
timeFrame: 12 weeks
measure: Diastolic blood pressure
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 6 weeks
measure: Waist circumference
timeFrame: 12 weeks
Locations:
city: Mannheim
country: Germany
facility: Stoffwechselzentrum Rhein-Pfalz
state: Baden-Württemberg
Study officials:
affiliation: Director of Stoffwechselzentrum Rhein-Pfalz
name: Per M Humpert, M. D.
role: PRINCIPAL_INVESTIGATOR
References: