Treatment of reactive hypoglycemia with macrobiotic Ma-Pi 2 diet as assessed by continuous glucose monitoring system

Completed

Conditions: Reactive hypoglycemia
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN84079151

Lead Sponsor: PM Un Punto Macrobiotico International Association (Italy)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 12

Inclusion Criteria

1. Non-diabetic patients
2. Both sexes
3. Aged at least 18 years old
4. BMI between 18 and 35 kg/m2
5. Able to provide written informed consent and to follow the procedures of the protocol
6. Previous diagnosis of RH, though it was confirmed by MMT before the enrolment

Exclusion Criteria

1. Impaired fasting glucose/impaired glucose tolerance/diabetic patients
2. Subjects affected by insulinoma or by other hypoglycemic endocrine conditions
3. Patients affected by any neoplasia
4. Patients affected by any food behavior disorders
5. Pregnant women
6. Symptoms of hypocalcemia
7. Known or suspected hypersensitivity to any of the ingredients of the administered diets
8. Patients under vitamin K antagonists or corticosteroid treatment
9. Subjects under any drugs therapy which might interfere with glucose metabolism

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the number of episodes of reactive hypoglycemia (blood glucose level below 70 mg/dL) in patients affected by such condition during macrobiotic Ma-Pi 2 diet administration compared to a same period during the administration of a low-GI diet.

Secondary Outcome Measures

Name	Time	Method
Glycemic distributions assessment through different readings (< 40; 41-50; 51-60; 61-70, 71-80, 81-90, 91-100, 101-110, 111-120, 121-130, 131-140, 141-150, 151-160, 161-170, 171-180 and > 180 mg/dL), measured and compared between the two dietary treatments