Potential of seaweed in reducing blood glucose of obese type 2 diabetes patients

Potential of seaweed in reducing blood glucose of obese type 2 diabetes patients - Effects of seaweed on blood glucose;"EndT2D""

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48790

Enrollment

Registered

2018-12-20

Start date

2019-05-13

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes type 2 diabetes mellitus

Interventions

Patients will receive either 5 gram of Sargassum fusiforme (Sargassum), Fucus vesiculosus (Fucus) or placebo (Nori) during 5 weeks (week 2-6). Clinical information (anamnesis and physiological exami

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with T2DM and BMI>25 - All adults; age * 18 years - Diabetes based on criteria of ADA - Informed consent

Exclusion criteria

Exclusion criteria: -Type 1 or monogenetic forms of diabetes. - Thyroid disease - Pregnancy - Usage of corticosteroids - Usage of blood coagulants - History of heartfailure or recent myocardial infarction within 3 months - Transplantation

Design outcomes

Primary

Measure	Time frame
The primary outcome is the difference between the mean blood glucose levels measured during the first week of usual diet and during the last 5 weeks of daily seaweed consumption. Effects of seaweed will be compared with the effect of placebo. Blood glucose will be monitored continuously by a device (Medtronic, Eindhoven) blinded for the participants.	—

Secondary

Measure	Time frame
Examine if Sargassum or Fucus supplementation results in bodyweight reduction and in improvement of risk factors for cardiovascular disease (CVD). Secondary outcomes are differences between week 1 and week 6 in terms of: * Body weight, Glucose, HbA1c, total daily insulin use, * Body weight, body mass index, waist-to-hip ratio, blood pressure, plasma lipids and peripheral blood phagocyte inflammatory activation status and ability to generate pro-angiogenic accessory cells from blood monocytes.	—

Measure

Time frame

Examine if Sargassum or Fucus supplementation results in bodyweight reduction and in improvement of risk factors for cardiovascular disease (CVD). Secondary outcomes are differences between week 1 and week 6 in terms of: * Body weight, Glucose, HbA1c, total daily insulin use, * Body weight, body mass index, waist-to-hip ratio, blood pressure, plasma lipids and peripheral blood phagocyte inflammatory activation status and ability to generate pro-angiogenic accessory cells from blood monocytes.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)