Overweight and Obesity in Relation to Type ll Diabetes Melitus

Mukuba University

Status: Not yet enrolling

Conditions: Overweight and Obesity; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Local Zambian Foods

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04016012

MU0619

Details and patient eligibility

About

The aim of the study is to evaluate the efficacy of local Zambian food in improving metabolic profiles of overweight/obese type ll diabetic patients in Kitwe district

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diabetic patients attending Kitwe Teaching Hospital
• 18 years and above
• Body Mass Index of 25 and above
• Willing to follow the diet plan and eat food provided
• Not enrolled in other clinical studies

Exclusion criteria

• Eating disorder or any psychosocial or scheduling factors that could impede study outcomes
• Have renal or liver problem
• Pregnant women
• Breast feeding women
• HIV positive individuals

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Participants in the intervention group will receive local zambian foods and standard health care for eight (8) weeks.

Treatment:

Dietary Supplement: Local Zambian Foods

Control arm

No Intervention group

Description:

The control group will have their usual (standard) diet in their home and receive standard health care for eight (8) weeks.